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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 Codes Injury (2348); No Code Available (3191)
Date of Event 03/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Medtronic complaint number: pe:(b)(4).
 
Event or Problem Description
According to the reporter, post-operatively, the device was used in an abdominal wall reconstruction tar wherein the patient incurred a temporary injury, having a recurrent incisional hernia.The location of the hernia was midline defect.The size of the defect was 23cm which was closed after the procedure by suture.Future surgery will be required in order to resolve the issue.
 
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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 Key6772319
Report Number9615742-2017-05198
Device Sequence Number14707905
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 user facility
Type of Report Initial
Report Date (Section B) 07/18/2017
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 NumberSPJ0706X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/18/2017
Initial Report FDA Received Date08/07/2017
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; Required Intervention;
Patient Age53 YR
Patient Weight64
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