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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMPOSITE MESH
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SOFRADIM PRODUCTION PARIETEX COMPOSITE MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 04/30/2014
Event Type  Injury  
Event Description

I had hernia repair surgery and implanted with parietx composite mesh. Hospitalized once for infection and then had to have the mesh surgically removed after another infection.

 
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Brand NamePARIETEX COMPOSITE MESH
Type of DeviceMESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
MDR Report Key4609208
MDR Text Key5633016
Report NumberMW5041457
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 03/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER

Patient TREATMENT DATA
Date Received: 03/10/2015 Patient Sequence Number: 1
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