• 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 SAS SYMBOTEX 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 SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM1510F
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic ventral hernia repair, during insertion into patient and using the absorbatack to fixate mesh onto the abdominal wall, a hole was shot in the mesh, resulting in a tack in the abdominal wall but no fixation for the mesh. The tack from the absorbatack shot a hole in the mesh. The device remains implanted. No injury to the patient. Tacks were fired normally from the device. The surgeon managed to fixate the mesh after the issue occurred. The surgeon succeeded in fixating the mesh with the absorbatack without making any more holes.
 
Manufacturer Narrative
Evaluation summary: a review of the device history record (dhr) has been performed. No failure that may relate to the reported conditions have been noted. The visual examination of the pictures shows that: 2 photos have been taken during the surgery. The sample was placed into the patient. The first photo shows that: one violet tack is clearly visible, placed at 3 stiches from the edge of the mesh. A hole was visible at the left of the tack described below. The brightness indicates the presence of the collagen on the mesh. Another purple mark placed on the left of the hole is visible but blurred. The second photo shows: 2 tacks fixed on the patient wall. The mesh is not placed on these but seems to be folded above. A yarn which seems to be of the mesh is visible near the tacker. The reported condition was confirmed. The product ifu (instructions for use) which accompanies each device states in chapter: operating steps that: the edge of the reinforcement should be at least 5 cm over the edges of the defect(s). The technique used to anchor the mesh (suture or staples) is left up to the practitioner. It is suggested to fixate the mesh at a distance of approximately 1cm from the edge of the mesh. Excessive tension is highly suspected. The report has been added to our database which is monitored for similar occurrences. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYMBOTEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux CT 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux CT 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7385477
MDR Text Key103973654
Report Number9615742-2018-00634
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM1510F
Device Catalogue NumberSYM1510F
Device Lot NumberPRJ0819X
Was Device Available for Evaluation? No
Date Returned to Manufacturer03/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-