Study: NCT03826667

Adverse event: RE-TEAR OF ROTATOR CUFF
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 193 at risk

Adverse event: LEFT SHOULDER ADHESIVE CAPSULITIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN AND DECREASED ROM
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RECURRENT RTC TEAR
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 193 at risk

Adverse event: R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER ADHESIVE CAPSULITIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR,
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR,
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: Splenic necrosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: CONTINUING SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: PAIN DOWN ARM TO LEFT HAND 4TH AND 5TH FINGERS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER BURSITIS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN WITH DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN AFTER PT STRENGTHENING EXERCISES
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT LATERAL EPICONDYLITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 193 at risk

Adverse event: LEFT TRICEPS TENDONITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: TINGLING FROM LEFT ELBOW TO WRIST
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT ELBOW WARM TO TOUCH WITH DECREASED MOBILITY AND PAIN RADIATING TO WRIST
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 193 at risk

Adverse event: INCREASED RIGHT SHOULDER PAIN R/T FALL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER INCREASED PAIN AND STIFFNESS R/T CATCHING FALLING CLIENT
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT ANKLE SPRAIN WITH SWELLING AND PAIN R/T FALL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER LIMITED ROM AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INCREASED PAIN RIGHT ANKLE
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: WORSENING PAIN RIGHT SHOULDER
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER IMPINGEMENT SYNDROME, WITH LIMITED ADLS AND NIGHT PAIN
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: NOCTURNAL AWAKENING DUE TO RIGHT SHOULDER TENDINOSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER SWELLING, REDNESS, WARMTH AND PAIN, CELLULITIS
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN, STIFFNESS, NUMBNESS AND DECREASED SENSATION RELATED TO RECURRENT RTC TEAR
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER ACHING PAIN WITH CERTAIN MOVEMENTS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER MILD PAIN AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: DECREASED LEFT SHOULDER STRENGTH
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER DECREASED ROM AND STRENGTH RELATED RTC RUPTURE
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN WITH DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER CONSTANT PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT ARM PAIN BICEP REGION AND LEFT SHOULDER SWELLING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: SMALL PARTIAL THICKNESS LEFT SUPRASPINATUS TEAR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: OCCASIONAL SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 193 at risk

Adverse event: NAUSEA AND CONSTIPATION R/T POST-OP OXYCONTIN
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: DISCOMFORT RIGHT BICEP INTO NECK AND DISUSE ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER PAIN AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER DULL PAIN AFTER STRENUOUS ACTIVITY
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INTERMITTENT LEFT SHOULDER PAIN SINCE EXERCISING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INTERMITTENT EPISODES OF PERSPIRING AND FEELING OF EXHAUSTION
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER WEAKNESS AND PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INTERMITTENT LEFT BICEP PAIN AND CRAMPING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INCREASED LUE PAIN WITH NUMBNESS AND TINGLING TO LEFT RADIAL DIGITS AND INSOMNIA RELATED TO PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INCREASING LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER BURSITIS WITH DECREASED ROM AND WEAKNESS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: THUMB PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN AND RESIDUAL WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER PAIN, LTD. ROM, WEAKNESS, DISUSE ATROPHY
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT RTC SMALL PARTIAL THICKNESS TEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER STIFFNESS, CONSTANT SORENESS, DECREASED ROM, ACHING AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT ANTERIOR SHIN NEURALGIA/SPRAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: MIGRAINE HEADACHES
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: OCCASIONAL DEEP LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT ARM WEAKNESS
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 193 at risk

Adverse event: ABDOMINAL PAIN AND CONSTIPATION
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: L SHOULDER PAIN W/LTD. ROM AND STRENGTH
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: LEFT SHOULDER EDEMA
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INCREASED LEFT SHOULDER PAIN, HYPERSENSITIVITY AND PARASTHESIA, QUESTION POSSIBLE RSD
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: CELLULITIS AND PURULENT DRAINAGE LEFT SHOULDER WOUND
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INTERMITTENT LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER PAIN WITH DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RIGHT SHOULDER PAIN WITH TIGHTNESS, WEAKNESS, AND DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: RECURRENT RTC TEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 193 at risk

Adverse event: RIGHT ROTATOR CUFF RE-TEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: MASS OF SOFT TISSUE OF RIGHT UPPER EXTREMITY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: INFECTION/SMALL HEMATOMA
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 193 at risk

Adverse event: WORSENING LEFT SHOULDER PAIN RADIATING DOWN LEFT ARM, RECURRENT LABRAL TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT RTC TEAR, RTC CAPSULE SPRAIN
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER PAIN WITH DECREASED ROM, STIFF AND SORE, ADHESIVE CAPSULITIS AND RTC TENDONITIS
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT SHOULDER PAIN, LTD ROM, RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: OCCASIONAL LEFT SHOULDER PAIN, STIFFNESS, ADHESIVE CAPSULITIS
Serious: yes
Organ System: Surgical and medical procedures
Notes: Probable to device
Frequency: 1 affected / 41 at risk

Adverse event: R SHOULDER TENDONITIS, PARTIAL RTC TEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: R SHOULDER ANTERIOR WOUND INFECTION
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: R SHOULDER PAIN, RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: R RTC TEAR, TENDONITIS AND WEAKNESS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: CONTINUING SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 4 affected / 41 at risk

Adverse event: OCCASIONAL SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 3 affected / 41 at risk

Adverse event: INTERMITTENT RIGHT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER ANTERIOR INCISIONS WITH MILD CELLULITIS
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: WORSENING LEFT SHOULDER PAIN AND SWELLING DUE TO FALLING IN SHOWER, CATCHING HERSELF WITH LEFT ARM
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER STIFFNESS AND LTD. ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER MILD TENDINOSIS, POSSIBLE SLAP TEAR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT ROTATOR CUFF TENDONITIS, ACJ IMPINGEMENT
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT SHOULDER SWELLING AND PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER STIFFNESS "SLEPT ON IT WRONG"
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: OCCASIONAL LEFT SHOULDER DECREASED ROM, PAIN, AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: SLIPPED OFF CURB AND FELL ONTO LEFT ARM
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: PAIN FROM LEFT SHOULDER STRAIN
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RETURNING LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unlikely related to device
Frequency: 1 affected / 41 at risk

Adverse event: R SHOULDER PAIN, DECREASED ROM AND BICEPS AREA PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT SHOULDER SURGICAL SCAR SENSITIVITY
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: PALPABLE TIGHTNESS RIGHT TRAPEZIUS AREA
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER INTERMITTENT PAIN AND DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: CONTINUING RIGHT SHOULDER PAIN AND DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: REACHING IN PT AND FELT A "POP" WITH INCREASED PAIN RIGHT SHOULDER
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RAISED RASH RIGHT FOREARM AND RIGHT ARMPIT
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: NAUSEA FROM PAIN MEDICATION
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: REDNESS AND SWELLING AROUND INCISION FRONT OF RIGHT SHOULDER
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT BICIPITAL GROOVE TENDERNESS AFTER OVERSTRETCHING IN PT
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: WORSENING PAIN RIGHT SHOULDER
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: GLENOHUMERAL INTERNAL ROTATION DEFICIT RIGHT SHOULDER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER CONTINUING PAIN
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER STIFFNESS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 41 at risk

Adverse event: WORSENING LEFT SHOULDER PAIN AND DECREASED ROM
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT KNEE ARTHROFIBROSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT SHOULDER PAIN AT NIGHT
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: CONTINUED POST-OP REVISION LEFT SHOULDER PAIN
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: POSSIBLE LEFT CUBITAL TUNNEL SYNDROME
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER POST. INCISION OPEN W/BLOOD DRAINAGE- SUTURE FELL OUT
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER WORSENING PAIN, LTD ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: ULNAR NERVE SYMPTOMS AND MEDIAL SCAPULAR PAIN, NECK PAIN
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: HERNIATED DISC WITH MYELOPATHY
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RECURRING RIGHT ELBOW PAIN, ACUTE RIGHT EPICONDYLITIS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: L SHOULDER PAIN, DECREASED ROM W/DIFFICULTY SLEEPING @ NIGHT, POSSIBLE ADHESIVE CAPSULITIS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT ELBOW PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT ELBOW STIFFNESS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT FOREARM PAIN AND MUSCLE SPASMS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT SHOULDER INSTABILITY AND PAIN R/T STRAIN/SPRAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: LEFT SHOULDER PAIN POST MUA, LOA
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RECURRENT RIGHT SHOULDER PAIN, POST-OP REVISION
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: RIGHT SHOULDER MUSCLE SPASMS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 41 at risk

Adverse event: ADHESIVE CAPSULITIS IN RIGHT SHOULDER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER ADHESIVE CAPSULITIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN AND DECREASED ROM
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RECURRENT RTC TEAR
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 78 at risk

Adverse event: R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER ADHESIVE CAPSULITIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR,
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR,
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: Complex regional pain syndrome
Serious: no
Organ System: General disorders
Notes: Unlikely related to device
Frequency: 1 affected / 78 at risk

Adverse event: CONTINUING SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 3 affected / 78 at risk

Adverse event: PAIN DOWN ARM TO LEFT HAND 4TH AND 5TH FINGERS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER BURSITIS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN WITH DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN AFTER PT STRENGTHENING EXERCISES
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT LATERAL EPICONDYLITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 78 at risk

Adverse event: LEFT TRICEPS TENDONITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: TINGLING FROM LEFT ELBOW TO WRIST
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT ELBOW WARM TO TOUCH WITH DECREASED MOBILITY AND PAIN RADIATING TO WRIST
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 78 at risk

Adverse event: INCREASED RIGHT SHOULDER PAIN R/T FALL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER INCREASED PAIN AND STIFFNESS R/T CATCHING FALLING CLIENT
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT ANKLE SPRAIN WITH SWELLING AND PAIN R/T FALL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER LIMITED ROM AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INCREASED PAIN RIGHT ANKLE
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: WORSENING PAIN RIGHT SHOULDER
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER IMPINGEMENT SYNDROME, WITH LIMITED ADLS AND NIGHT PAIN
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: NOCTURNAL AWAKENING DUE TO RIGHT SHOULDER TENDINOSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER SWELLING, REDNESS, WARMTH AND PAIN, CELLULITIS
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN, STIFFNESS, NUMBNESS AND DECREASED SENSATION RELATED TO RECURRENT RTC TEAR
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER ACHING PAIN WITH CERTAIN MOVEMENTS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER MILD PAIN AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: DECREASED LEFT SHOULDER STRENGTH
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER DECREASED ROM AND STRENGTH RELATED RTC RUPTURE
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN WITH DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER CONSTANT PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT ARM PAIN BICEP REGION AND LEFT SHOULDER SWELLING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: SMALL PARTIAL THICKNESS LEFT SUPRASPINATUS TEAR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: NAUSEA AND CONSTIPATION R/T POST-OP OXYCONTIN
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: DISCOMFORT RIGHT BICEP INTO NECK AND DISUSE ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER PAIN AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER DULL PAIN AFTER STRENUOUS ACTIVITY
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INTERMITTENT LEFT SHOULDER PAIN SINCE EXERCISING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INTERMITTENT EPISODES OF PERSPIRING AND FEELING OF EXHAUSTION
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER WEAKNESS AND PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INTERMITTENT LEFT BICEP PAIN AND CRAMPING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INCREASED LUE PAIN WITH NUMBNESS AND TINGLING TO LEFT RADIAL DIGITS AND INSOMNIA RELATED TO PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INCREASING LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER BURSITIS WITH DECREASED ROM AND WEAKNESS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: THUMB PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN AND RESIDUAL WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER PAIN, LTD. ROM, WEAKNESS, DISUSE ATROPHY
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT RTC SMALL PARTIAL THICKNESS TEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER STIFFNESS, CONSTANT SORENESS, DECREASED ROM, ACHING AND WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT ANTERIOR SHIN NEURALGIA/SPRAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: MIGRAINE HEADACHES
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: OCCASIONAL DEEP LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT ARM WEAKNESS
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 78 at risk

Adverse event: ABDOMINAL PAIN AND CONSTIPATION
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: L SHOULDER PAIN W/LTD. ROM AND STRENGTH
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: LEFT SHOULDER EDEMA
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INCREASED LEFT SHOULDER PAIN, HYPERSENSITIVITY AND PARASTHESIA, QUESTION POSSIBLE RSD
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: CELLULITIS AND PURULENT DRAINAGE LEFT SHOULDER WOUND
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: INTERMITTENT LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER PAIN WITH DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RIGHT SHOULDER PAIN WITH TIGHTNESS, WEAKNESS, AND DECREASED ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 78 at risk

Adverse event: RECURRENT RTC TEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 78 at risk

Adverse event: RE-TEAR OF ROTATOR CUFF
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT CARPAL TUNNEL WITH RELEASE
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 1 affected / 136 at risk

Adverse event: R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 1 affected / 136 at risk

Adverse event: RECURRENT TEAR OF ROTATOR CUFF WITH NEW TEAR OF THE SUPRASPINATUS AND RECURRENT JOINT IMPINGEMENT
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER ADHESIVE CAPSULITIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 136 at risk

Adverse event: LEFT SHOULDER PAIN WITH RECURRENT RTC TEAR
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: DECREASED ROM RIGHT SHOULDER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: PNEMOTHORAX- RIGHT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: SHOULDER PAIN POST FALL
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT HAND NUMBNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER TENDINITIS/BURSITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT SHOULDER DISCOMFORT SECONDARY TO FALL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER ANTERIOR PORTAL REDDENED AND SWOLLEN WITH RESOLVING BICEP ECCHYMOSIS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: CONTINUED LEFT SHOULDER WEAKNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: ACTIVE RANGE OF MOTION LIMITED BY PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: BICEPS ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: SHOOTING PAIN DOWN LEFT ARM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT HAND CONTUSION
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: ADHESIVE CAPSULITIS RIGHT SHOULDER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: INCREASE IN RIGHT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: NEW ONSET ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT ARM LIMITED ROM SECONDARY RIGHT SHOULDER PAIN FROM LIFTING INJURY
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT BICEPS TENDONITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT SHOULDER ADHESIVE CAPSULITIS POST RCR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: PAINFUL HERNIATED CERVICAL DISC WITH MYELOPATHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: BILATERAL SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER INCREASING PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER CLICKING, NUMBNESS LEFT ARM, LEFT 4TH AND 5TH FINGERS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: NIGHTMARES FROM PERCOCET
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: INSOMNIA R/T LEFT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER PAIN WITH EXERCISING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER STIFFNESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT SHOULDER SORENESS
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: EXACERBATION HYPERTENSION
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: BICEPS TENDONITIS RIGHT SHOULDER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: NUMBNESS RIGHT THUMB
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: HERNIATED DISC WITH MYELOPATHY, CONTINUED RIGHT ARM WEAKNESS, RIGHT SCAPULA AREA AND SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: WORSENING RIGHT SHOULDER PAIN AND SWELLING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: FALL CAUSING RIGHT SHOULDER FORCED ABDUCTION
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT SHOULDER SORENESS AT TIMES
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: ROTATOR CUFF SPRAIN/STRAIN LEFT SHOULDER
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 136 at risk

Adverse event: INSOMNIA SECONDARY TO RIGHT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: LEFT HAND THIRD FINGER PARONYCHIA VERY PAINFUL AND TENDER
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: POSTERIOR/LATERAL NUMBNESS RIGHT ARM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RIGHT SHOULDER SWELLING
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: PAINFUL ROM
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RECURRENT 6MM RIGHT RTC TEAR SECONDARY TO DIABETES AND SMOKING CAUSING POOR TISSUE QUALITY
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: INCREASING RIGHT SHOULDER PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: ROTATOR CUFF SPRAIN/STRAIN RIGHT SHOULDER
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 136 at risk

Adverse event: RE-TEAR OF ROTATOR CUFF
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: ROTATOR CUFF RETEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unlikely related to device
Frequency: 1 affected / 57 at risk

Adverse event: SEVERE CENTRAL SPINAL STENOSIS
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: Generalised anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: RIGHT ELBOW INJURY, POSSIBLE FRACTURE, OCCURRED DUE TO FALL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: MASS OF SOFT TISSUE OF RIGHT UPPER EXTREMITY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: CLAVICLE FRACTURE AFTER FALL AT WORK
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: Splenic necrosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: PNEMOTHORAX- RIGHT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: PAIN ON THE RIGHT SIDE OF HER SHOULDER DOWN HER NECK AND THE MEDIAL BORDER OF HER RIGHT SCAPULA.
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: RIGHT SIDE ARM PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: SHOULDER PAIN POST FALL
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 59 at risk

Adverse event: ROTATOR CUFF FAILURE / RECURRENT TEAR
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 1 affected / 59 at risk