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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL MESH FOR HERNIA REPAIR

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SURGICAL MESH FOR HERNIA REPAIR Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problems Pain (1994); Scar Tissue (2060)
Event Type  Injury  
Event Description

Hernia repair 1998. Several years later, hernia returned, had another hernia repair using a mesh to repair hernia. Few years later, hernia was painful, the mesh previously used showed hernia was back, and was larger and painful. Now on (b)(6) 2017 i am to go in for another hernia repair with another mesh again. I had heard there was a recall on a mesh used for hernia repair, and i was told by hospital my hernia repair mesh was not one recalled. Surgeon told me mesh is "changed every 6 or so years. " i am to go into same day surgery (b)(6) 2017, and i should be about 2 hours long because they will be dealing with old scar tissue from previous hernia repair with mesh a few years back and instead of a 1 hr surgery. It would probably be up to 2 hrs long.

 
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Brand NameSURGICAL MESH FOR HERNIA REPAIR
Type of DeviceSURGICAL MESH FOR HERNIA REPAIR
MDR Report Key6639655
MDR Text Key77639009
Report NumberMW5070399
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/12/2017 Patient Sequence Number: 1
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