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

Model Number PCO6VP

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the absorbable ring broke upon insertion of the mesh during an open umbilical hernia repair.There was no adverse event as a result of the device malfunction.A new device was used to complete the procedure.

Manufacturer Narrative

Reference number: (b)(4).

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, including those records specifically related to the molding of the ring.The sample was not returned in its original packaging but in a biohazard bag.One patient label was stuck on a cardboard sheet.The returned sample consisted of a bloody mesh.The handles and the textile were found as expected.The collagen-based film was found bloody and damaged.One ring (white handle side) was found broken at one location.The appearance of the collagen-based indicated that the mesh was folded collagen film face against collagen film face at the crack location.Based on this information it was determined that the mesh was misused.Based on 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.

• 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: 5722585
• MDR Text Key: 47302869
• Report Number: 9615742-2016-00078
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101519
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2016; 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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