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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
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
Health Effect - Clinical Codes Hernia (2240); Injury (2348)
Date of Event 12/07/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem 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 Name
VERSATEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key7175632
Report Number9615742-2018-00083
Device Sequence Number14643337
Product Code FTL
Combination Product (Y/N)N
PMA/510(K) Number
K150091
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Type of Report Initial
Report Date (Section B) 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberVTX5050M
Device Catalogue NumberVTX5050M
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2017
Initial Report FDA Received Date01/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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