MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PROGRIP PRECUT W/FLAP RIGHT SIDE; MESH, SURGICAL, POLYMERIC

Model Number TEM1409GR

Device Problem Material Rupture (1546)

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

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a laparoscopic hernia repair, the mesh tore.The procedure was completed with another piece of mesh and there was no effect to the patient.Additional information has been requested but not yet received.

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 quality specifications, specifically those records related to the mechanical testing of the textile batch used for this lot.No product was provided for evaluation.The visual examination of the provided pictures showed that a part of the mesh is bloody, which indicates use and manipulation of the device within the body.The dimensions could not be checked and the product verified.Tears were observed at the pre-cut hole location.There are 2 locations where the textile appears overstretched and torn.Without the sample, a detailed investigation could not be performed.Based on the available information, misuse and excessive manipulation are suspected.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.

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 quality specifications, particularly those regarding the quality records 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.The sample consists of a bloody mesh and the tyvek lid with patient labels.Mesh dimensions and textile knitting pattern were found as expected.The flap was not correctly positioned: the flap was found under the mesh.The pre-cut hole was found over-stretched and torn: approximatively 1.5 cm x 3.7 cm.Several stitches were found cut near the colored yarn marker.A search of our database revealed that this was the only report on file for this lot of product.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.It is suspected that there was excessive manipulation or rough handling.

• Brand Name: PARIETEX PROGRIP PRECUT W/FLAP RIGHT SIDE
• 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: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5831295
• MDR Text Key: 50723670
• Report Number: 9615742-2016-00097
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: TEM1409GR
• Device Catalogue Number: TEM1409GR
• Device Lot Number: SQA0088X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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