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

Model Number PCO8VP

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

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 the umbilical hernia repair via laparoscopic procedure, while taking down adhesions and then attempted to insert the device and it would not lay flat. The surgeon took the device out and tried again for that same piece. Then opened another device and tried it again still with the same condition. There was an extended surgical time of 30 minutes or more and to complete the case, the surgeon opened a new one with a different size that worked. 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12900193
• MDR Text Key: 281502251
• Report Number: 9615742-2021-02435
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PVF0097X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial