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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
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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