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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD MONOFILAMENT KNITTED POLYPROPYLENE MESH
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BARD MONOFILAMENT KNITTED POLYPROPYLENE MESH Back to Search Results
Catalog Number REF 0112720
Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)
Patient Problems Flatus (1865); Failure of Implant (1924); Pain (1994); Infection, Direct (2244); Hematuria (2558)
Event Type  Injury  
Event Description
I had bard mesh placed in a bilateral inguinal hernia repair. The mesh came in 6x6 squares and they were, according to the surgical report, cut down to 3. 5 x 3. 5 and a 3. 5 strip on the other side. A month or so after, i began to have intestinal trouble. After 11 years, it hasn't gotten better only worse, blood in my urine, hernia came back 1 year later. Intestinal infections, prostate infections, drs can't find the cause, partial intestinal blockage. Ct shows mesh failure. X ray shows surgical tacks protruding through the pelvic wall. Feel run down and bloated so much that i can only lay down to sleep for 4 to 5 hours before the bloating and pain wakes me up.
 
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Brand NameMONOFILAMENT KNITTED POLYPROPYLENE MESH
Type of DeviceMONOFILAMENT KNITTED POLYPROPYLENE MESH
Manufacturer (Section D)
BARD
MDR Report Key5790207
MDR Text Key49523926
Report NumberMW5063355
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberREF 0112720
Device Lot Number43JND027
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? 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: 07/09/2016 Patient Sequence Number: 1
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