MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number	TECR1515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/17/2010
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, post-operatively, the infected mesh caused massive infection that broke to the surface.This continued through 11 operations until all the mesh was out.A portable pump was used to heal quicker until it reinfected each time.The dressing was changed three times a week.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 10672963
• Report Number: 9615742-2020-02340
• Device Sequence Number: 14080565
• Product Code: FTL
• UDI-Device Identifier: 10884521180291
• UDI-Public: 10884521180291
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TECR1515
• Device Catalogue Number: TECR1515
• Device Lot Number: SKB00345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1