MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 6C; PARIETEX MESH

Catalog Number PCO6VP

Device Problems Crack (1135); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

Procedure: demo.According to the reporter: after a defective device was opened at one of my accounts, we opened another one (pco4vp lot number rne9997) and the barrier did the same thing.It was very brittle and snapped off by touching it.There was also a very large piece that cracked off.It was very brittle.I opened several of my demo pieces and some were far more brittle than others and really "cracked" when touching them.Some were fine.The following samples will be sent in for evaluation: pco4vp lot number rne9997 pco4vp lot number pnj0295 pco4vp lot number pnk0116 pco6vp lot number pnj0282.After the incident at the hospital i wanted to check my demo products and all of the above came from my demo.They may have been subjected to very cold temperatures either in transit to me or in my trunk and i am curious if this has anything to do with the "brittleness" of them.

Manufacturer Narrative

(b)(4).

• Brand Name: PCO VENTRAL PATCH 6C
• Type of Device: PARIETEX MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 ; FR F-01
• Manufacturer Contact: sharon murphy ; 60 middletown ave.; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3738044
• MDR Text Key: 4278325
• Report Number: 9615742-2014-00113
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: PCO6VP
• Device Lot Number: PNJ0282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1