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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN/ SOFRADIM PARIETEX HERNIA MESH
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COVIDIEN/ SOFRADIM PARIETEX HERNIA MESH Back to Search Results
Model Number 60566569
Event Date 12/02/2009
Event Type  Injury  
Event Description

Hernia mesh failed needed new surgery on (b)(6) 2010. Used paritex mesh. First mesh was not found when they did 2 surgeries. Just had a cat scan done and they found it at the bottom of my stomach.

 
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Brand NamePARIETEX HERNIA MESH
Type of DevicePARIETEX HERNIA MESH
Manufacturer (Section D)
COVIDIEN/ SOFRADIM
MDR Report Key6559912
Report NumberMW5069693
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number60566569
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/09/2017 Patient Sequence Number: 1
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