Company Unit CDER-CTU Originating Account FAERS

Source Medium MWO (Drug) Source Form Type E2B XML 3500

Priority High

Override Auto Calculation Rule No

FDA Received Date 14-Jul-2023 CTU Received Date 14-Jul-2023

CTU Triage Date CTU Data Entry Date

Report Type Spontaneous Report Classification Drug

Assign To User

User/Group

Forward to Department

Case Priority Direct

Patient Identifier (In Confidence)

Age

Date of Birth 10-Apr-2023

Sex Female

Gender Cisgender woman/girl

Please Specify Other Gender

Weight 0.81 kg

Ethnicity (Check single best

answer)

Not Hispanic/Latino

Race (Check all that apply) Asian

 American Indian or Alaska Native

 Black or African American

 White

 Native Hawaiian or Other Pacific Islander

(b) (6)

Type of Report (check all that

apply) Adverse Event

 Product Use/Medication Error

 Product Problem (e.g., defects/malfunctions)

 Problem with Different Manufacturer of Same Medicine

Serious Yes

Outcome Attributed to Adverse

Event (Check all that apply) Death

 Life Threatening

 Hospitalization (initial or prolonged)

 Other Serious or Important Medical Events

 Disability or Permanent Damage

Receipt No: RCT-1147039 FDA 3500 Form

CTU No.: FDA-CDER-CTU-2023-51808 | Department: CFSAN | RCT No.: RCT-1147039 | CTU Triage Date: 17-Jul-2023 | Total Pag 

es: 4 

All dates displayed in the report are in EST(GMT-05:00) time zone

Basic Details

Contact

Case First Name Last Name Email Address Phone

Reporter

(b) (6)

A. PATIENT INFORMATION

B. ADVERSE EVENT, PRODUCT PROBLEM

Generated by: SYSTEM Generated on: 14-Jul-2023 14:45:31 Page 1 of 4
Congenital Anomaly/Birth Defects

 Required Intervention to Prevent Permanent Impairment/Damage

Date of Death 27-Apr-2023

Date of Event 27-Apr-2023

Date of this Report 14-Jul-2023

Receipt No: RCT-1147039 FDA 3500 Form

CTU No.: FDA-CDER-CTU-2023-51808 | Department: CFSAN | RCT No.: RCT-1147039 | CTU Triage Date: 17-Jul-2023 | Total Pag 

es: 4 

Describe Event, Problem or Product Use Error

Describe Event, Problem, or Product Use Error: 24 week premature birth given neonatal Bifidobacterium Infantis 0.04 gram (8

bill cell/0.5mL Oral Liquid 0.5 mL (EVIVO WITH MCT OIL). Sepsis developed with probiotic strain above cultured.

Relevant Test/Laboratory Data 1 of 1

Test Name BACTERIAL RDNA SEQU

ENCING

Test Date 17-Apr-2023

Test Result genetically consistent with 

bifidobacterium longum

Test Unit

Low Test Range High Test Range

More Information Available?

Additional Comments

Other Relevant History, Including Preexisting Medical Conditions

premature birth

C. PRODUCT AVAILABILITY

Product Available for Evaluation? No

(Do not send product to FDA)

Returned to Manufacturer on

Do you have a picture of the No

product? (check yes if you are

including a picture)

D. PRODUCT(S) 1 of 1

Suspect Yes

Primary? Yes

Type Drug/Biologic

This report involves: Dietary Supplement

Name,Strength,Manufacturer/Compounder (from product label)

Product Name Bifidobacterium Infantis (8 bill cell/0.5mL Oral Liquid) EVIVO MCT oil

Strength If Other

Manufacturer/Compounder Evivo

Generated by: SYSTEM Generated on: 14-Jul-2023 14:45:31 Page 2 of 4
NDC# or Unique ID no NDC

Product Type(check all that

apply) OTC

 Compounded

 Generic

 Biosimilar

Event Abated After Use Stopped No

or Dose Reduced?

Event Reappeared after Doesn't Apply

Reintroduction ?

Brand Name

Common Device Name

Procode

Manufacturer Name

City

State

Model #

Lot #

Catalog #

Expiration Date

Serial #

Unique Identifier (UDI)#

Operator of Device Health Professional

 Patient/Consumer

 Other

Other

If Implanted, Give Date

Receipt No: RCT-1147039 FDA 3500 Form

CTU No.: FDA-CDER-CTU-2023-51808 | Department: CFSAN | RCT No.: RCT-1147039 | CTU Triage Date: 17-Jul-2023 | Total Pag 

es: 4 

Drug Therapy 1 of 1

Dose or Amount 0.04 G gram(s) If Other

Frequency Daily If Other

Route Oral If Other

Dosage Form

Start 13-Apr-2023

Stop 25-Apr-2023

Dose Reduced

Therapy Duration If Other

Is therapy still on-going? No

Lot Number

Expiration Date

Diagnosis for Use (indication) 1 of 1

prematurity

E. SUSPECT MEDICAL DEVICE

Generated by: SYSTEM Generated on: 14-Jul-2023 14:45:31 Page 3 of 4
Receipt No: RCT-1147039 FDA 3500 Form

CTU No.: FDA-CDER-CTU-2023-51808 | Department: CFSAN | RCT No.: RCT-1147039 | CTU Triage Date: 17-Jul-2023 | Total Pag 

es: 4 

If Explanted, Give Date

Is this a single-use device that

was reprocessed and reused on

a patient?

If Yes for the above field,

Enter Name and Address of

Reprocessor

Was this device serviced by a

third party?

F. OTHER (CONCOMITANT) MEDICAL PRODUCTS

CONCOMITANT MEDICAL PRODUCT DESCRIPTION

G. REPORTER 1 of 1

Primary? Yes

Reporter is Patient?

Title

Last Name

Middle Name

First Name

Address

City

State/Province/Region

Country UNITED STATES If Other

ZIP/Postal Code

Phone

Email

Fax

Reporter Organization

Department

Reporter Speciality

Health Professional? Yes

Occupation Pharmacist If Other

Also Reported to Manufacturer/Compounder

 User Facility

 Distributor/Importer

If you do NOT want your identity

disclosed to the manufacturer

No

(b) (6)

(b) (6) (b) (6) Generated by: SYSTEM Generated on: 14-Jul-2023 14:45:31 Page 4 of 4