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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 VTX1106
Device Problems Degraded (1153); Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a left open inguinal hernia repair, while being applied into the groin the mesh was damaged. While the surgeon was cutting of the mesh the surgeon saw the mesh unravel at the cut edges and further reinforcement was required. Operative approach was to plug and patch. The size of the defect was 2. 5 cm. The appearance of the mesh was normal before use, but after use, the mesh was fraying badly. To resolve the issue, another piece of mesh was used which resulted in the patient having three (3) mesh pieces implanted. The fixation used was sutures. No patient injury.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7409950
MDR Text Key104818950
Report Number9615742-2018-00810
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K150091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberVTX1106
Device Catalogue NumberVTX1106
Device Lot NumberSQE0511X
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 Received03/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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