• 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 SYM9F
Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Patient Problems Prolapse (2475); Blood Loss (2597); No Code Available (3191)
Event Date 06/28/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during laparoscopic ventral hernia repair, when about five firings were performed to place mesh, it peeled off and further tacking (s) was performed and the procedure was completed, but the mesh peeled off a few days later. The part fell into the patient's cavity and was retrieved. Oozing bleeding occurred as a result of the issue. An open procedure was done. The procedure was completed with another device.

 
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 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8810102
MDR Text Key151702313
Report Number9615742-2019-02608
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK131969
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,Followup
Report Date 09/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYM9F
Device Catalogue NumberSYM9F
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/30/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/21/2019 Patient Sequence Number: 1
-
-