MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PG RECT 30X15CM; MESH

Model Number TEM3015G

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Procedure: ventral hernia repair.According to the reporter, the mesh was placed in retrorectus space in order to support ventral hernia closure via myofascial flaps.The patient returned 3 months later with recurrence and upon reoperation, mesh was incorporated into tissue laterally, however had torn right down the midline for the entire piece of mesh.Additional information requested but not yet received.

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX PG RECT 30X15CM
• Type of Device: MESH
• 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: 4827170
• MDR Text Key: 5902534
• Report Number: 9615742-2015-00052
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TEM3015G
• Device Catalogue Number: TEM3015G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1