MAUDE Adverse Event Report: SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1; MESH, SURGICAL, POLYMERIC

Model Number SYM2015

Device Problem Hole In Material (1293)

Patient Problem Seroma (2069)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, there was a hole in the mesh when the surgeon had to re-operate on the patient.Additional information indicated that the surgeon had operated on the gentleman 9 months prior.The patient kept returning to the office with a seroma.The surgeon finally convinced the patient to re-open his abdomen to see what was going on.The surgeon found a 2mm hole in the mesh.The surgeon closed the hole with two interrupted sutures.Other then the hole in the mesh, the mesh appeared fine.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Per additional information, the device was cut into a circular shape before implantation.The hole in the device was not at a suture point location.A combination of two types of tacking fixation systems were used to fixate the mesh.The hernia was 2cm in the patient body before the device was implanted.The procedure performed was an primary umbilical hernia repair.The tissue integrated well, and there was no evidence of recurrence.

Manufacturer Narrative

(b)(4).As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with the finished product specifications for all released lots.No sample was provided for investigation.The visual examination of the provided pictures shows that the hole is located near the green colored polyester marking.The visible piece of mesh reveals good integration except at the hole location.A comparison between commercial picture of the device, the provided scheme and the sample pictures was performed.Without the sample a detailed investigation could not be performed.The report has been added to our product complaints database which is monitored for similar occurrences.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.Based on the incident description, the surgeon closed the hole with two interrupted sutures, there is no patient impact.No immediate action required.A lack of integration of this pore of 3d monofilament polyester textile is highly suspected.This is an isolated case.

• 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: 5346743
• MDR Text Key: 35163348
• Report Number: 9615742-2016-00002
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• 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
• Patient Age: 67 YR
• Patient Weight: 106