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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 Date 12/07/2017
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

According to the reporter, the patient underwent a procedure for a midline hernia, while they used a robotic transversus abdominis release operative approach, the mesh was torn with an 11 cm. Defect post operatively. The mesh appearance was normal. The mesh was cut prior to implantation. The wound was closed with suture. The patient had incurred a hernia recurrence. The location of the hernia was midline. An additional operation was needed to correct the issue. The patient was alive.

 
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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 Key7175632
Report Number9615742-2018-00083
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVTX5050M
Device Catalogue NumberVTX5050M
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 Received12/13/2017
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

Patient TREATMENT DATA
Date Received: 01/09/2018 Patient Sequence Number: 1
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