MAUDE Adverse Event Report: GENZYME SEPRAFILM

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

Patient Problems Adhesion(s) (1695); Edema (1820); Inflammation (1932); Pain (1994)

Event Date 04/08/2016

Event Type  Injury  

Event Description

Seprafilm was used in my hysterectomy and i believe my adhesions, and fluid in abdomen, pelvic pain and inflammation are a result of this product.

• Brand Name: SEPRAFILM
• Type of Device: SEPRAFILM
• Manufacturer (Section D): GENZYME
• MDR Report Key: 6587358
• MDR Text Key: 75959349
• Report Number: MW5070003
• Device Sequence Number: 1
• Product Code: MCN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR
• Patient Weight: 123