MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX RND 9CM X1; MESH, SURGICAL, POLYMERIC

Model Number PCO9X

Device Problem Torn Material (3024)

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

Event Date 05/15/2015

Event Type  malfunction  

Event Description

Procedure: hernia repair.According to the reporter, when opened to the sterile field, the mesh was torn.There was no delay in surgery.A new box was opened to complete the case.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one returned device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.A visual examination of the returned device showed a tear of the collagen-based film and textile at one edge.A review of the device history record was conducted and it was confirmed that the device was released meeting all quality specifications.There has only been one report for this type of occurrence including this one.Based on the information available at this time, no corrective action is required.Should additional information be received, the record will be reassessed at that time.(b)(4).

• Brand Name: PARIETEX PCOX RND 9CM X1
• 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: 4819498
• MDR Text Key: 5917871
• Report Number: 9615742-2015-00050
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: POJ0148X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1