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

Model Number TEM1409GL

Device Problem Torn Material (3024)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the mesh ripped while placing.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).Evaluation summary - a review of the device history record has been performed.This review confirmed that this lot of products was released according to quality assurance specifications.Visual examination of the returned sample showed that the mesh was torn from the middle to the opposite edge of the flap.The mesh part at the opposite side of the colored yarn marker seemed to have been cut.The reported condition was confirmed a search of the global complaints database revealed that this was the only report on file for this lot of product.Based on 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.Should additional information be received, the record will be reopened and reassessed at that time.

• Brand Name: PARIETEX PROGRIP PRECUT W/FLAP LEFT 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5049541
• MDR Text Key: 25501355
• Report Number: 9615742-2015-00081
• 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: health professional
• Reporter Occupation: Nurse
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: TEM1409GL
• Device Catalogue Number: TEM1409GL
• Device Lot Number: SOL0780X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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