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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYCO HEALTHCARE COVIDIEN PARIETEX COMPOSITE 30 X 20 CM MESH PARIETEX COMPOSITE MESH

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TYCO HEALTHCARE COVIDIEN PARIETEX COMPOSITE 30 X 20 CM MESH PARIETEX COMPOSITE MESH Back to Search Results
Lot Number PIF00365
Event Date 03/22/2011
Event Type  Injury  
Event Description

Mesh product implanted during surgery for incisional hernia on (b)(6) 2011. Product split almost entirely in half and pt was returned to surgery on (b)(6) 2011 for removal and surgical repair.

 
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Brand NamePARIETEX COMPOSITE 30 X 20 CM MESH
Type of DevicePARIETEX COMPOSITE MESH
Manufacturer (Section D)
TYCO HEALTHCARE COVIDIEN
MDR Report Key2037666
Report NumberMW5020014
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/31/2013
Device LOT NumberPIF00365
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/29/2011 Patient Sequence Number: 1
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