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

Model Number	PCOPM15H50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Failure of Implant (1924); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: abstack20 5mm sgl use abs dev 20 tacks (lot#:noa0558), abstack20s sht 5mm sgl use abs dev 20 (lot#:n9l0350u).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of parastomal and ventral hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, extensive adhesions of small bowel and omentum to the mesh as well as small bowel obstruction.Post-operative patient treatment included multiple mesh revision surgeries.

• 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: 9249850
• Report Number: 9615742-2019-03525
• Device Sequence Number: 2311418
• Product Code: FTL
• UDI-Device Identifier: 10884521177772
• UDI-Public: 10884521177772
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: 10/31/2013
• Device Model Number: PCOPM15H50
• Device Catalogue Number: PCOPM15H50
• Device Lot Number: PIK00456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PCO1510OS COMP 15X10CM OS VERSION(LOT#::PJA00589)
• Outcome Attributed to Adverse Event: Required Intervention