To the best of your knowledge, have you suffered from any of the following: Medical Condition Sought treatment for? Indicate whether condition occurred pre-implant, or both (explain, if necessary) Adhesions Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Bleeding or Clotting Disorders If Yes, please specify disorder: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Bowel Obstruction Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Bowel Perforation Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Cancer If Yes, please specify type: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Chronic Constipation Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Collagen Disorder/Deficiency Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Connective Tissue Disorder If Yes, please specify disorder: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Crohn’s Disease, Irritable Bowel Syndrome, Ulcerative Colitis, or Chronic Diarrhea If Yes, please specify which condition and treatment prescribed: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ implant
Cystocele Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Diabetes Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Diverticulitis Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Dyspareunia Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Enterocele Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Fistulas Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Hernias Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Hypertension or High Blood Pressure Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Hypotension or Low Blood Pressure Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Immune System Disease or Dysfunction including HIV/AIDS If Yes, please specify condition: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Malnutrition Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Muscle or Disorder If Yes, please specify disorder: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Neuromuscular Disease or Disorder If Yes, please specify disorder: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Obesity Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Pelvic Trauma Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___
If Yes, please describe trauma: Pelvic Tumors or Fibroids Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Peritonitis/Sepsis Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Rectocele Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Recurrent or Chronic Vaginal or Bladder Infections If Yes, please specify location and nature of infections: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Recurrent Vaginal Pain If Yes, please describe the nature of pain experienced: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Urinary Incontinence Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Urinary Retention Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Uterine Prolapse Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Vaginal Vault Prolapse Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Healing Problems If Yes, please explain: Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___ Any other disease of the gut, intestines, or bowels If Yes, please specify condition (s): Yes ___ No ___ Yes ___ No ___ Pre ___ Post ___
The documents are attached [OR] I have no documents Produce all documents concerning any communication between you and the Food and Drug Administration (FDA) or between you and any employee or of the Defendants, regarding the pelvic mesh product(s) at issue, except as to those communications which are attorney client/work product privileged. i. Not Applicable ii. The documents are attached [OR] I have no documents Produce all documents in your possession, custody or control evidencing or relating to any correspondence or communication between either you or Coloplast Corp., (or any of its related companies or divisions) with any of your doctors, healthcare providers, and/or you relating to the pelvic mesh product(s), except as to those communications which are attorney client/work product privileged. Not Applicable The documents are attached [OR] I have no documents Produce any and all documents in your possession, custody or control reflecting, describing, or in any way relating to any instructions or warnings you received to implantation of any pelvic mesh product(s) concerning the risks and/or benefits of your surgery, including but not limited to any risks and/or benefits associated with the pelvic mesh product(s). Not Applicable The documents are attached [OR] I have no documents Produce any and all documents reflecting the model number and lot number of the pelvic mesh product(s) you received. Not Applicable The documents are attached [OR] I have no documents If you underwent surgery to explant in whole or in part the pelvic mesh product(s) that you received: produce any and all documents in your possession, custody or control aside from documents that may have been generated by experts retained by your counsel for litigation purposes, relating to any evaluation of the pelvic mesh product(s) and any other material that was (were) surgically removed from you.