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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP 3D PY 30X20CM NO THRX1 PARIETEX COMPOSITE MESH

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SOFRADIM PRODUCTION PARIETEX COMP 3D PY 30X20CM NO THRX1 PARIETEX COMPOSITE MESH Back to Search Results
Catalog Number PCO3020
Event Date 03/21/2011
Event Type  Injury  
Event Description

Procedure type: hernia. According to the reporter: the product split in half post-operatively, causing pt distress and emergent re-operation and repair.

 
Manufacturer Narrative

(b)(4).

 
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Brand NamePARIETEX COMP 3D PY 30X20CM NO THRX1
Type of DevicePARIETEX COMPOSITE MESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux FR F -016
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux FR F -016
Manufacturer Contact
terry callahan
60 middletown ave
north haven , CT 06473
2034926273
MDR Report Key2095034
Report Number9615742-2011-00037
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPCO3020
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/23/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/09/2011 Patient Sequence Number: 1
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