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

Model Number LPG1510AR

Device Problems Split (2537); Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Procedure: inguinal hernia repair.According to the reporter, the mesh tore during deployment in vivo.There were no adverse effects as a result of the reported event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).A review of the device history record has been performed.No finding related to the reported condition has been found.This review confirmed that this lot of products was released according to quality specifications.Review of quality control records related to the mechanical testing of the textile batch used for this lot confirms compliance to the specifications.No product was provided for evaluation.The visual examination of the provided picture reveals a very bloody mesh torn across the length.However, it is neither possible to determine where the tear is located: seam, flap or another part of the mesh; nor the root cause of the tear: cut, pre-existing tear, excessive manipulation, etc.Without the sample a detailed investigation could not be performed.Based on our investigation, the available information 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.If additional information is obtained, or the sample is returned, we will re-open this investigation.

• Brand Name: LP PRGRP ANTMCL MSH10X15CM RT
• 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: 4778259
• MDR Text Key: 5820204
• Report Number: 9615742-2015-00042
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K142900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

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 Expiration Date: 03/31/2016
• Device Model Number: LPG1510AR
• Device Catalogue Number: LPG1510AR
• Device Lot Number: POJ0620X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR