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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 12/29/2016
Event Type  Injury  
Manufacturer Narrative

To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operatively, the unknown product, ventral mesh fracture. The issue was confirmed with computerized tomography. The surgery was performed. Patient status was unknown.

 
Manufacturer Narrative

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

 
Event Description

According to the reporter: as per the additional information received, the product ventral mesh fracture. Fracture of the mesh resulted in hernia recurrence. The procedure was a hernia. The location of the hernia was ventral / incisional. Open transversus abdominis release operative approach / technique was performed. The size of the defect was 15x25cm. 4x transfascial fixation sutures - pds fixation system was used. Four fixation points were applied. Mesh was not damaged during the procedure. Ct scan was done. An additional operation will be performed to correct the issue. Patient status : stable, with hernia recurrence. Pre-existing conditions and/or comorbidities for the patient : (b)(6), non-smoker, bmi 23.

 
Manufacturer Narrative

Product analysis: examination: no product was provided for evaluation. A mesh seems to be visible and 2 ¿big¿ hernia holes are visible besides the mesh (one on the left and one on the right). Without the sample a detailed investigation could not be performed. 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 Key7050118
Report Number1219930-2017-08987
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2017
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 NumberSPJ1016X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/19/2015
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: 11/21/2017 Patient Sequence Number: 1
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