MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated for follow up dated 21-jun-2017: this case concerns a patient who received treatment with seprafilm in hysterectomy and later developed fluid in abdomen, pelvic pain and inflammation.The role of the product in occurrence of the events cannot be denied.However, surgical intervention in itself is a possible risk for occurrence of such events.

Event Description

Pelvic pain [pelvic pain], inflammation [inflammation], fluid in abdomen [intra-abdominal fluid collection].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on 14-jun-2017 from patient via health authority (food and drug administration-department of health and human sciences: mw5070003) this case concerns a female patient (age unspecified) who received application of seprafilm and after an unknown latency had fluid in abdomen, pelvic pain and inflammation.Concomitant medication includes transvaginal mesh, tvt (tension-free vaginal) tape for bladder, topiramate (topamax), hydrocodone bitartrate/paracetamol (vicodin), ergocalciferol (vitamin d), ethinylestradiol/norethisterone acetate (microgestin), otc (over the counter) medications: multivitamin.No relevant medical history, past drugs or concurrent conditions was reported.On an unknown date, patient had placement of seprafilm once (route, form, dose, batch number and expiration date: not reported) in hysterectomy for postoperative adhesion barrier.On (b)(6) 2016, after unknown latency, patient had adhesions, fluid in abdomen, pelvic pain and inflammation, patient believed that it was a result of this product.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: medically significant for all events.Pharmacovigilance comment: sanofi company comment dated for follow up dated 21-jun-2017: this case concerns a patient who received treatment with seprafilm in hysterectomy and later developed fluid in abdomen, pelvic pain and inflammation.The role of the product in occurrence of the events cannot be denied.However, surgical intervention in itself is a possible risk for occurrence of such events.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 10453922
• MDR Text Key: 212359138
• Report Number: 1220423-2020-00018
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention