MAUDE Adverse Event Report: SOFRADIM PRODUCTION STEX ROUND 9CM (3.6'"); NONE

Catalog Number SYM9

Device Problem Material Puncture/Hole (1504)

Patient Problem Fistula (1862)

Event Type  Injury  

Event Description

(b)(6), who claims that he used a 9cm round symbotex mesh in a robotic ventral hernia repair two weeks ago.During the procedure, the mesh was punctured twice.The patient returned with a bowel fistula within a week of the original surgery.

Manufacturer Narrative

(b)(4).

• Brand Name: STEX ROUND 9CM (3.6'")
• Type of Device: NONE
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux 0160 0; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux 0160 0; FR 01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3876305
• MDR Text Key: 18931340
• Report Number: 9615742-2014-00215
• Device Sequence Number: 1
• Product Code: OTN
• 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: Other
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SYM9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention