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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS VERSATEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS VERSATEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number VTX5050M
Device Problems Adverse Event Without Identified Device or Use Problem; Torn Material
Event Type  Injury  
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, following a open ventral hernia repair, while they were using an onlay/sublay approach, there was a midline hernia failure with a 50x50 defect found during post op follow-up care. They used a suture for wound closure and fixation system. The patient was alive with no injury.

 
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Brand NameVERSATEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
Manufacturer Contact
sharon murphy
60 middletown ave
north haven , CT 06473
2034925267
MDR Report Key7107822
Report Number9615742-2017-05975
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVTX5050M
Device Catalogue NumberVTX5050M
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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