• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 05/12/2017
Event Type  Injury  
Event Description

According to the reporter the patient experience a recurrent incisional hernia. The location of the hernia is midline. The patient will require repair, there will be an additional operation to correct the issue. The current patient status is alive with injury. The mesh implant procedure (approx. 9 months previous) was an open repair of recurrent ventral incisional hernia, abdominal wall reconstruction, bilateral posterior transverse abdominus release and mayofascial medial advancement flaps. The size of the defect was 30cm x 27cm. The mesh was not cut prior to implantation. The mesh was not implanted in a contaminated field. The mesh was fixated by suture, the wound was closed by suture after the procedure. Mesh tore in patient post operation. Patient is scheduled for a repair of this recurrence on (b)(6) 2017. Pictures are available and will be provided. Patient medical history: previous bypass surgery, hernia repairs, allergies fish and iodine.

 
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.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one image depicting a ct scan of an abdomen where the device was implanted. No product and no picture were provided for evaluation. A ct scan video was provided. Without the sample a detailed investigation could not be performed. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures; additionally, a review of the device history records has been performed. This review confirmed that this lot of products was reviewed and released according to qa specifications. The root cause of the observed condition could not be reliably determined. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6694548
Report Number9615742-2017-05180
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVTX5050M
Device Catalogue NumberVTX5050M
Device LOT NumberSPJ0706X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2015
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: 07/07/2017 Patient Sequence Number: 1
-
-