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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 Code Torn Material (3024)
Health Effect - Clinical Codes Hernia (2240); Injury (2348)
Type of Reportable Event Serious Injury
Additional 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.
 
Event or Problem Description
According to the reporter: the patient underwent a robotic assisted repair of recurrent ventral incision hernia.The defect size was 22x22cm.The mesh was cut prior to implant and was fixed with strata fix suture.The mesh was not damaged.Post-operatively, the mesh torn and the hernia has recurred.Future surgical intervention will be required to fix hernia.There was temporary injury.The patient is alive with injury.Medical history: crowns disease, sleep apnea, high blood pressure.
 
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Brand Name
VERSATEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux
MDR Report Key6868165
Report Number9615742-2017-05236
Device Sequence Number12260058
Product Code FTL
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional,user faci
Type of Report Initial
Report Date (Section B) 08/21/2017
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
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/21/2017
Initial Report FDA Received Date09/15/2017
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;
Patient Weight136
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