MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN SYMBOTEX MESH; MESH, SURGICAL, POLYMERIC

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the surgeon reported seeing the mesh ripped apart.It was stated that the mesh was handled with a regular grasper and not something sharp or with teeth.The report was received from a surgeon that was performing a reoperation and no further information has been made available.

• Brand Name: UNKNOWN SYMBOTEX MESH
• 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: 5673070
• MDR Text Key: 45697332
• Report Number: 9615742-2016-00037
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention