MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 6C; MESH, SURGICAL, POLYMERIC

Model Number PCO6VP

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Hernia (2240)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the collagen layer on one side of the mesh did not stick against the mesh.There was no reported patient injury or adverse event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Reference number: (b)(4).Based on sample examination, the involved product is a pco6vp with lot #rpi0119x.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, including the manufacturing records related to the collagen film casting, drop off the textile and drying, and the manufacturing records related to the films cutting were found within specifications.The visual examination of the returned sample shows the following: the sample was returned in its original packaging.The box and consumer labels indicate that the lot number is rpi0119x.Mesh dimensions, textile knitting and handles positioning were found as expected.The collagen film was found dry with traces of blood next to one junction of the violet expanders.The overlap of the collagen film was found gathered on the visceral side (collagen based film).One piece of the collagen film overlap was broken.After rehydration of the film with saline solution as required per the product instructions for use (ifu), the collagen film was found as expected except at the break location.It has been concluded, by visual examination, that excessive manipulation could have induced the break of the piece of the collagen film overlap.After rehydration, no other anomalies were observed regarding the collagen film.The product ifu indicates that the patch must be hydrated in its original blister before being handled.This is carried out by immersing it completely in sterile saline solution for several seconds in order for it to recover its conformability and flexibility.Based on our investigation, 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.(b)(4).

• Brand Name: PCO VENTRAL PATCH 6C
• 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: 5466454
• MDR Text Key: 39232943
• Report Number: 9615742-2016-00007
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: RPI0019X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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