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

Model Number	PPDS15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/16/2020
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, 11 months postoperatively, the patient experienced a recurrence of ventral hernia.

• Brand Name: PARIETENE DS
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 12092580
• Report Number: 9615742-2021-01597
• Device Sequence Number: 19827403
• Product Code: FTL
• UDI-Device Identifier: 10884521553460
• UDI-Public: 10884521553460
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 12/31/2020
• Device Model Number: PPDS15
• Device Catalogue Number: PPDS15
• Device Lot Number: RTA1748X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/30/2021
• 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
• Patient Age: 42 YR
• Patient Weight: 79