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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Event or Problem Description
According to the reporter: the patient underwent an open midline hernia procedure.The operative approach was onlay or sublay.The size of the defect was 50 x 50.The mesh was not cut prior to implantation.The mesh was no implanted in a contaminated field.The wound was closed normally using sutures.The patient had to come back for a re-operation.There was medical or surgical intervention needed to prevent a permanent impairment of a function.The event lead to or extended the patient's hospitalization time.The patient outcome is alive, no injury.
 
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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 Key6832056
Report Number9615742-2017-05213
Device Sequence Number12127394
Product Code FTL
Combination Product (Y/N)N
PMA/510(K) Number
K150091
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Type of Report Initial
Report Date (Section B) 08/02/2017
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 08/02/2017
Initial Report FDA Received Date08/30/2017
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 Hospitalization; Other; Required Intervention;
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