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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP 30X20CM W THR X1 PARIETEX COMPOSITE MESH

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SOFRADIM PRODUCTION PARIETEX COMP 30X20CM W THR X1 PARIETEX COMPOSITE MESH Back to Search Results
Catalog Number PCO3020F
Event Date 04/30/2012
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter: the customer reports that a pt, on whom the device has been applied some time ago, had to be re-operated. During the procedure, the surgeon found out that the intestine was sticking on the whole surface of the mesh.

 
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Brand NamePARIETEX COMP 30X20CM W THR X1
Type of DevicePARIETEX COMPOSITE MESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FRANCE
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FRANCE
Manufacturer Contact
melissa zaffin
60 middletown ave
north haven , CT 06473
2034927141
MDR Report Key2617881
Report Number9615742-2012-00240
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Foreign,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPCO3020F
Device LOT NumberPJJ00486
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/09/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2009
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/07/2012 Patient Sequence Number: 1
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