MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP 3D PY 30X20CM NO THRX1 PARIETEX COMPOSITE MESH

Catalog Number PCO3020

Device Problems Detachment Of Device Component (1104); Split (2537)

Patient Problem No Code Available (3191)

Event Date 03/21/2011

Event Type  Injury  

Event Description

Procedure type: hernia. According to the reporter: the product split in half post-operatively, causing pt distress and emergent re-operation and repair.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX COMP 3D PY 30X20CM NO THRX1
• Type of Device: PARIETEX COMPOSITE MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux FR F -016
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux FR F -016
• Manufacturer Contact: terry callahan ; 60 middletown ave; north haven, CT 06473 ; 2034926273
• MDR Report Key: 2095034
• MDR Text Key: 20955106
• Report Number: 9615742-2011-00037
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/23/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2011
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PCO3020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/09/2011 Patient Sequence Number: 1