MAUDE Adverse Event Report: SOFRADIM PRODUCTION LP PRGRP ANTMCL MSH10X15CM LT MESH, SURGICAL, POLYMERIC

Model Number LPG1510AL

Device Problem Hole In Material (1293)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a bilateral inguinal hernia repair, a hole was detected in the mesh. The defect did not result in any adverse consequences. Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Reference number: (b)(4). A review of the device history record has been performed. This review confirmed that this lot of products was released according to quality specifications, specifically those related to the mechanical testing of the textile batch used for this lot. The visual examination of the returned sample showed that: the sample was not returned in its original packaging. Only an opened blister was returned with mesh. No patient label was returned with the sample; mesh dimensions were found as expected. The mesh does not appear to have been used within the patient; a 3 cm-hole is visible in the seam, 8 mm far from the stopping point. The seam yarn is broken at several locations: after the stopping point, 3 cm further and a part of free yarn is in the middle. The reported condition was confirmed by sample examination. The root cause of the hole in the seam is broken yarn. The root cause of the broken yarn could not be reliably determined. The report has been added to our 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 is required.

Manufacturer Narrative

(b)(4).

• Brand Name: LP PRGRP ANTMCL MSH10X15CM LT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5554601
• MDR Text Key: 42087641
• Report Number: 9615742-2016-00015
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2018
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: RPH0404X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown