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

Model Number PCO6VP

Device Problems Loss of or Failure to Bond (1068); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during an intraperitoneal onlay mesh procedure, on the epigastric area, the violet expanders were broken.The mesh was damaged by 3cm.The mesh failed to deploy open after insertion into the peritoneal cavity.The wound was closed with sutures after the case.The client opened up another mesh to resolve the issue.There was no patient injury.

• 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: 10437857
• MDR Text Key: 203878020
• Report Number: 9615742-2020-01861
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514157
• UDI-Public: 10884521514157
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PTL2321X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/21/2020
• Date Device Manufactured: 12/31/2019
• 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