MAUDE Adverse Event Report: SOFRADIM PRODUCTION PERMACOL 20X30 1.5MM; MESH, SURGICAL, POLYMERIC

Model Number 5230-150

Device Problem Torn Material (3024)

Patient Problem Hernia (2240)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient underwent an initial operation on (b)(6) 2016 for a recurrent hernia, and the device was implanted.On (b)(6) 2016, the patient got a "burst" stomach due to relapsing cough.An immediate re-operation was necessary.During the reoperation, the device was found to be ripped in the area of the fixation seams.It was also found to have defects in the net area where no seam fixation was made.The device was explanted.

Manufacturer Narrative

(b)(4).A visual examination of the returned device revealed the following: the sample was not returned in its original packaging but in a container with saline solution; the mesh had been cut; there were holes and a tear at different locations of the mesh (not only at the fixation points); and the tears were not in the direction of the fibers.It was determined, based on the physical evaluation of the device, that a combination of potential residual infection of the implantation site and excessive tension on the mesh due to chronic coughing may have induced the observed tears and holes.Based on the instructions for use (ifu) that accompany the device, it is stated that if the surgical implant is shaped too small for the defect, excessive tension may be placed on the sutures and possibly result in recurrence of the original tissue defect or development of a defect in the adjacent tissues.As the device was cut prior to implantation, it is not known if there was adequate overlap to ensure sufficient margins for incorporation to the surrounding tissues.A review of the device history record (dhr) has been performed.This review confirmed that this lot of products was reviewed and released according to quality specifications, including records related to bioburden and sterilization.Should additional information become available, the record will be re-evaluated and amended as needed.

Event Description

Additional information indicated that the mesh was saved in a sodium chloride solution.The reconstruction was performed with a non-absorbable mesh, despite the raised risk of infection (per the doctor's words).It was also reported that the mesh did not provide enough stability.

• Brand Name: PERMACOL 20X30 1.5MM
• 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: 5467368
• MDR Text Key: 39264215
• Report Number: 9615742-2016-00006
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 5230-150
• Device Catalogue Number: 5230-150
• Device Lot Number: AOL0559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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 Outcome(s): Required Intervention