• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GORE MEDICAL GORE DUALMESH BIOMATERIAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GORE MEDICAL GORE DUALMESH BIOMATERIAL Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceGORE DUALMESH BIOMATERIAL
Manufacturer (Section D)
GORE MEDICAL
MDR Report Key6108922
MDR Text Key60312493
Report NumberMW5066089
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received11/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2011
Device Model NumberOCMX24
Device Catalogue Number1DLMCTP66
Device Lot Number0643-4718
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
-
-