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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERNIA MESH MESH, SURGICAL, POLYMERIC

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HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Sticking (1597)
Patient Problems Death (1802); Unspecified Infection (1930)
Event Date 04/01/2015
Event Type  Death  
Event Description
My dad had hernia mesh surgery (b)(6). He developed infection as the mesh adhered to his bowels. He had surgery (b)(6) to remove the infection and the mesh. He never left the hospital and passed away (b)(6).
 
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Brand NameHERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key7009547
MDR Text Key91441728
Report NumberMW5073167
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 11/08/2017 Patient Sequence Number: 1
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