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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL MESH

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SURGICAL MESH Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Irritation (1941); Pain (1994); Discomfort (2330)
Event Date 01/16/2015
Event Type  Injury  
Event Description
In 2006, i had surgery to correct an incisional hernia, dr. (b)(6) was the surgeon and he used mesh to repair the hernia. I do not know the manufacturer of the mesh. Sometime in late 2013 or 2014, i began noticing a great amount of discomfort in the area of the surgery. I first though it was either my button or snap on my pants irritating the area. Then i thought maybe it was that i was eating. Then i wondered if the hernia could be back. Finally i consulted first my pcp, who examined me and could find no evidence of another hernia. Then i went to another dr who said it was the mesh being irritated that was causing my problems. His suggestion was to wear bigger pants. Then i went back to dr. (b)(6) and he said basically the same thing. The mesh sometimes gets irritated, but it should go away in a couple of months. He also said if he took the mesh out, my hernia would return. It's been more than a year, and sometimes the pain in my abdominal area is so intense, it is difficult to conduct my daily activities. I wish i had known this before the surgery.
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MDR Report Key5401872
MDR Text Key37305706
Report NumberMW5059810
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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