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

Model Number PCOPM20

Device Problem Torn Material (3024)

Patient Problems Tissue Damage (2104); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter,following a laparoscopic repair of a parastomal hernia procedure using a modified sugarbaker operative app roach, the mesh was damaged.The surgeon observed a fracture of the mesh corresponding to the translucent stripe, where this originally covered the hernia defect.There was tissue damage and the patient experienced bowel obstruction as a result of the product problem.The surgical time was extended 30 minutes or more and the event also resulted to an extended patient hospital stay.The patient underwent reoperation for parastomal hernia to resolve the issue and to prevent permanent impairment.

Manufacturer Narrative

Evaluation summary: the visual examination of the provided picture shows that, a hole is visible in the middle of the mesh.Tackers are placed well, the distance from the edge of the mesh was found conform.The bowel is passing through the middle of the mesh by the hole.A review of the device history record has been performed.No failure or non-conformance (ncr) that may relate to the reported conditions has been noted.The report has been added to our product complaints database which is monitored for similar occurrences.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.No immediate action required.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7637652
• MDR Text Key: 112314304
• Report Number: 9615742-2018-01364
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: 10884521177789
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K081126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Device Lot Number: PPI0631X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR