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

Model Number	PCOPM20
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hernia (2240); No Code Available (3191)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic parastomal hernia repair for recurrent parastomal hernia, it was found that the mesh applied to the abdominal wall had a hole.During explantation, the mesh was cut in pieces so that it can be taken out.The patient's hospitalization was extended by 4 days.
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 parastomal hernia repair for recurrent parastomal hernia, it was found that the mesh applied to the abdominal wall had a hole.During explantation, the mesh was cut in pieces so that it can be taken out.The patient's hospitalization was extended by 7 days.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, two years following a parastomal hernia repair procedure, the patient presented with pain but without symptoms of bowel obstruction and was scheduled for elective laparoscopic recurrent hernia repair.During the procedure, it was confirmed that the mesh was fractured and a hole was noted in the middle of the mesh.The mesh was explanted and was taken out in pieces through the trocar.The patient was hospitalized by seven days.

• 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: 7881141
• Report Number: 9615742-2018-02097
• Device Sequence Number: 1909643
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: 10884521177789
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2018

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: 06/30/2020
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Device Lot Number: PPF0836X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 09/19/2018; 09/17/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/19/2018; 10/26/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 70