MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX THR 37X28CM X1; NONE

Catalog Number PCO3728FX

Device Problems Hole In Material (1293); Material Separation (1562); Torn Material (3024)

Patient Problem Tissue Damage (2104)

Event Date 07/25/2014

Event Type  Injury  

Event Description

A pco mesh was implanted into a patient and had to be removed from the patient after 2 days.The patient had been coughing and the mesh had torn at various points where it separated from the tacker.The mesh has numerous holes.There were areas where the mesh had not torn out of the fixation but the fixation had pulled out of the tissue.Fixation tack was evident in the mesh.The synthetic mesh was replaced with a biologic at the second surgery.

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX PCOX THR 37X28CM X1
• Type of Device: NONE
• 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: 4007974
• MDR Text Key: 16992841
• Report Number: 9615742-2014-00251
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PCO3728FX
• Device Lot Number: POC0884X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Age: 56 YR