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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 03/01/2017
Event Type  Injury  
Manufacturer Narrative

Medtronic complaint number: pe:(b)(4).

 
Event Description

According to the reporter, post-operatively, the device was used in an abdominal wall reconstruction tar wherein the patient incurred a temporary injury, having a recurrent incisional hernia. The location of the hernia was midline defect. The size of the defect was 23cm which was closed after the procedure by suture. Future surgery will be required in order to resolve the issue.

 
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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 Key6772319
Report Number9615742-2017-05198
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2017
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 NumberSPJ0706X
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 Received07/18/2017
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: 08/07/2017 Patient Sequence Number: 1
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