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

Model Number	PCOPM20
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fever (1858); Radiation Exposure, Unintended (3164)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: the patient underwent an open parastomal hernia procedure.Post operatively, the mesh was stuck to the intestine and caused a prolonged fever of the patient.The mesh was not folded at the two violet expander junctions and was not folded facial side against facial side.The mesh was not cut prior to implantation.The appearance of the mesh was normal.The fixation system was a tacker with sixty fixation points and a 12 mm trocar was used.The wound was closed with sutures.Post procedure the patient had a prolonged fever and the doctor therefore performed ct scan and discovered the bowel is sticking to the mesh.The surgeon re-opened the wound and confirmed the sticking and corrected the issue.The collagen side of the mesh was facing the visceral.No other symptoms have been reported.No infection was reported.The patient had no further 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: as per the additional information received, no bowel injury during the intraperitoneal composite mesh repair.The bowel was found to densely adhered to the side of mesh with anti-adhesive coating.They also reopen the wound and double confirm the sticking.Collagen side is facing the visceral.Current status of the patient: alive.

• 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: 7045587
• Report Number: 9615742-2017-05817
• Device Sequence Number: 16580695
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: 10884521177789
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 07/31/2022
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Device Lot Number: PRG1022X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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: Required Intervention