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

Model Number	PPM3030X3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/04/2018
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, during a laparoscopic procedure, the device caused infection on the surgical site.

• Brand Name: PARIETENE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7507329
• Report Number: 9615742-2018-01125
• Device Sequence Number: 1333668
• Product Code: FTL
• UDI-Device Identifier: 20884521213859
• UDI-Public: 20884521213859
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K142091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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 Expiration Date: 01/31/2022
• Device Model Number: PPM3030X3
• Device Catalogue Number: PPM3030X3
• Device Lot Number: SRB1336X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other