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

Model Number	PCOPM15
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Prolapse (2475); No Code Available (3191)
Date of Event	10/16/2018
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, post parastomal hernia wherein sugarbaker technique was used, a reoperation was performed following a reoccurrence of hernia of a patient who used mesh.At that time, there was a round hole of about 5 cm around the center of the center band and the hernia reoccurred.It was confirmed that the mesh was under adhering to the abdominal wall around the hole.The hernia was closed with suture and the operation was completed.
Additional Manufacturer Narrative
Evaluation summary: no sample was returned for investigation; however, a photo was provided.The visual examination of the provided picture (video camera) shows a well-integrated mesh placed in the abdominal wall.However due to the picture quality, it is not possible to determine where exactly is located the hole in the mesh (2d-band or 3d-band), if it is a tear or a cut, and if the mesh have been overstretched or not.Without the sample a detailed investigation could not be performed.The root cause could not be determined.As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with qa specifications for all product lots prior release to market.If information is provided in the future, a supplemental report will be issued.

• 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: 8059538
• Report Number: 9615742-2018-02539
• Device Sequence Number: 2792546
• Product Code: FTL
• UDI-Device Identifier: 10884521177758
• UDI-Public: 10884521177758
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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 Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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