MAUDE Adverse Event Report: GORE MEDICAL GORE DUALMESH BIOMATERIAL

Model Number OCMX24

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Anemia (1706); Arthritis (1723); Hair Loss (1877); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Perforation (2001); Swelling (2091); Constipation (3274)

Event Date 11/10/2009

Event Type  Injury  

Event Description

Reporter states that on (b)(6) 2009, she was implanted with the gore dualmesh. Prior to the surgery, she saw her physician due to abdominal pain. She was told that she had "3 muscles stretched out" and needed the mesh to correct this. After the surgery, she felt constant intense abdominal pain. Six weeks later, she returned for her follow-up; still complaints of pain; she was told that she needed more time to heal. She returned 1 month later again still complaints of pain and was told that she still needed more time to heal. This continued for years and had ct scans done at (b)(6) hospitals. She was eventually told that the mesh protruded and was "sticking" to her bowels, so no doctor wanted to remove it because it would cause more damage than to leave it in. Reporter states that one physician prescribed her antidepressants and told her that some of her problems are "in her head. " in addition to the abdominal pain, she also experiences constipation, abdominal swelling, a weak immune system, inflammation, skin sagging, loss of muscle tissue, hair loss, arthritis, infections, hypertension, hypotension and low iron levels. She has been taking iron pills to correct this but her iron levels are still low. On her last visit to the ed, she was told to see a gastroenterologist who said that she has h. Pylori infection which may have began when she was implanted with the device. She says that the gi sent her to the er and the er sends her back. She is tired of going back and forth over and over again because no one wants to help her.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: GORE DUALMESH BIOMATERIAL
• Manufacturer (Section D): GORE MEDICAL
• MDR Report Key: 6108922
• MDR Text Key: 60312493
• Report Number: MW5066089
• Device Sequence Number: 1
• Product Code: FTL
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/01/2011
• Device Model Number: OCMX24
• Device Catalogue Number: 1DLMCTP66
• Device Lot Number: 0643-4718
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 11/15/2016 Patient Sequence Number: 1