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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX COMPOSITE MESH, SURGICAL, POLYMERIC

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COVIDIEN PARIETEX COMPOSITE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number N/A
Event Date 05/21/2014
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Removal of infected mesh. Infected parietex mesh with subfascial abscess.

 
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Brand NamePARIETEX COMPOSITE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
60 middletown avenue
north haven CT 06473
MDR Report Key5418789
Report Number5418789
Device Sequence Number1
Product CodeFTL
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberN/A
Device Catalogue NumberPCO3020
Device LOT NumberPJB00391
OTHER Device ID Number30 X 20 CM
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2015
Event Location Hospital
Date Report TO Manufacturer11/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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