MAUDE Adverse Event Report: GENZYME CORP. SEPRAFILM ADHESION BARRIER; BARRIER, ABSORB-ABLE, ADHESION

Model Number 508602

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

Patient Problems Chest Pain (1776); Diarrhea (1811); Edema (1820); Headache (1880); Lupus (1956); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544); Abdominal Distention (2601)

Event Date 06/18/2012

Event Type  Injury  

Event Description

Reporter states that on (b)(6) 2012 she underwent surgery to remove a pelvic mass.She states that the surgeon implanted a seprafilm barrier without her consent.Since that day her "life has gone downhill." she was diagnosed with lupus.She has been out of work, has experienced distention, diarrhea, migraines, kidney and liver issues, thyroid issues, edema, chest pain, back pain, pain in her left leg, burning sensation in her abdomen and ambulation difficulties (uses a walker).She has had 3 miscarriages but was worried because she is unable to provide for her children due to her illness.

• Brand Name: SEPRAFILM ADHESION BARRIER
• Type of Device: BARRIER, ABSORB-ABLE, ADHESION
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 7302618
• MDR Text Key: 101313486
• Report Number: MW5075578
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• 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: 02/27/2018

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
• Device Model Number: 508602
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR