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

Model Number LPG1612AR

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, while opening the mesh, during a laparoscopic bi lateral inguinal hernia transabdominal pre-peritoneal technique, the mesh had a 2-3cm damage.Both meshes reported had a crease in them that could not be pulled apart.They used a new mesh, which was also faulty, with the same batch number.They opened another mesh with a different batch number to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was returned for investigation.A review of the device history record has been performed by trevoux quality assurance.No failure or ncr that may relate to the reported conditions have been noted.The visual examination of the returned sample shows that; 2 samples were provided in their original packaging.The textile knitting pattern, the sewing and the mesh dimensions were found as expected.Sample 1: the tyvek lid was opened, the collagen film was found partially delaminated.It seems to have been hydrated in the blister.Trace of collagen adhered to the blister.Sample 2: the tyvek lid was sealed, conclusion of the visual examination: the reported condition was not confirmed.The reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROGRIP
• 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: 7654569
• MDR Text Key: 112861755
• Report Number: 9615742-2018-01422
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513228
• UDI-Public: 10884521513228
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143386
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: LPG1612AR
• Device Catalogue Number: LPG1612AR
• Device Lot Number: PSB0890X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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