MAUDE Adverse Event Report: SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH/15 CM X 10 CM; MESH, SURGICAL, POLYMERIC

Model Number SYM1510OS

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the physician was having difficulty with adhering the mesh during a procedure.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicated that there was no injury to the patient.The mesh was able to be implanted once fully hydrated and facing the appropriate direction within the cavity.The procedure was a laparoscopic ventral hernia repair.No further information has been received.

Manufacturer Narrative

(b)(4).Additional information:the reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.

• Brand Name: SYMBOTEX COMPOSITE MESH/15 CM X 10 CM
• 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: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5888519
• MDR Text Key: 52511574
• Report Number: 9615742-2016-00110
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM1510OS
• Device Catalogue Number: SYM1510OS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• 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