• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1 MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceMESH, 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 Key5346743
MDR Text Key35163348
Report Number9615742-2016-00002
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
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 Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM2015
Device Catalogue NumberSYM2015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2016
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 Unkown

Patient Treatment Data
Date Received: 01/06/2016 Patient Sequence Number: 1
-
-