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

Model Number LPG1510AL

Device Problem Torn Material (3024)

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

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the surgeon opened and inserted a piece of the alleged device through an 8mm trocar and noticed the mesh was perforated perfectly along the superior edge, from right to left.The defect was noticed after the product was manipulated inside the patient, and the mesh was not cut before implantation.When the surgeon grabbed the device with his graspers, it tore along the perforation.The collagen film was rehydrated.A suture was placed near pubic tubercle in order to fixate the device.In order to correct the condition, another device was used.There was no reported patient injury or adverse event.

Manufacturer Narrative

(b)(4).A review of the device history record has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications.Especially, the review of qc records related to the mechanical testing of the textile batch (textile lot #tpk0715, cqr361192; and textile lot #tqb0309, cqr361641) used for this lot confirms compliance to the specifications.No product was provided for evaluation.The visual examination of the provided pictures reveals that the bloody mesh was cut straight from one side (green band) to the opposite one (white textile) in the part with collagen film.However, without the sample a detailed investigation could not be performed.It should be noted that when lpg mesh textile tears, the stitches fray and the tear is not as regular as in the picture provided.It should be also noted that based on note #7, an 8mm trocar was used to insert the mesh into the patient body.The product ifu which accompanies each device states grasp the mesh at either end and insert it through the trocar.It is recommended to use a trocar of at least 10mm internal diameter to introduce a mesh of size up to 15x10 cm and a trocar of at least 12mm internal diameter to introduce a mesh of size 16x12 cm or above.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 required.

Manufacturer Narrative

(b)(4).Method: a review of the device history record has been performed.This review confirmed that this lot of products was reviewed and 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 the following: the sample was returned in its original primary packaging without the outer packaging.The biohazard bag was found opened by a cut.The temperature dot was found as expected.The mesh dimensions measured and matched those associated with the reported device.The bloody mesh appeared to have been cut straight from one side (white textile) to the opposite one (green band) in the part with collagen film.The grasper caught the mesh at the white textile area above the seam.A scanning electron microscope (sem) image was performed at different locations of the mesh damages.A straight damage was observed.This damage did not seem to result from a thermic issue.The root cause of the damage could not be determined.It should be noted that when lpg mesh textile tears, the stitches fray and the tear is not as regular as in the provided sample.It should be also noted that an 8mm trocar was used to insert the mesh into the patient body.The product instructions for use (ifu) which accompanies each device states instructs the user to "grasp the mesh at either end and insert it through the trocar.It is recommended to use a trocar of at least 10mm internal diameter to introduce a mesh of size up to 15x10 cm and a trocar of at least 12mm internal diameter to introduce a mesh of size 16x12 cm or above".A search of our global complaints database revealed that this was the only report on file for this lot of product.The report has been added to our product complaints 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.Improper use is suspected as the trocar used was an 8mm trocar instead of at least a 10 mm trocar.

• 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 road; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5953420
• MDR Text Key: 55212161
• Report Number: 9615742-2016-00118
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: RQD0277X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1