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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 Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
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 reporter: open procedure - ventral hernia repair. The physician does not know the exact date of the procedure. She stated that it was implanted in (b)(6). The patient was reported with a hernia recurrence.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key6672898
Report Number9615742-2017-05174
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 06/26/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2017
Is This An Adverse Event Report? Yes
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 Received06/26/2017
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

Patient TREATMENT DATA
Date Received: 06/28/2017 Patient Sequence Number: 1
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