• 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 SYM2015OS
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
Patient Problems Edema (1820); Pain (1994); Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 04/03/2017
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: pmv lead an evaluation of the device. The visual examination of the returned sample shows that the sample was returned wrap in a material and placed in an aluminum packaging. Mesh dimension and textile were found as expected, except that they are contaminated by blood. The sewing between both parts of the mesh was found as expected too. 19 tacks are attached and placed all around the mesh in the open-skirt. Two holes are visible in the central part. One hole seems to be overstretched, the other hole seems to result from a cut. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: a review of the device history record has been performed. This review confirmed that this lot of products was reviewed and released according to qa specifications. The visual examination of the returned sample shows that the sample was returned wrap in a material and placed in an aluminum packaging. Mesh dimension and textile were found as expected, except that they are contaminated by blood. The sewing between both parts of the mesh (central and open-skirt) was found as expected too. 19 tacks are attached and placed all around the mesh in the open-skirt (green textile). 2 holes are visible in the central part. One hole seems to be overstretched, the other hole seems to result from a cut. The root cause could not be reliably determined. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: the patient underwent an open abdominal wall hernia repair procedure. An absorbable tacking device was used to attach the mesh. The patient was discharged from the hospital on the same day of the procedure. Later that night, the patient developed abdominal pain and was hospitalized. A computerized tomography (ct) scan was performed and observed like a dropsy (edema). An ileus tube was placed, however, the symptom did not improve. A reoperation was performed sixteen days after the original procedure. It was observed that the mesh had a hole and part of the intestine, "approximately the half-length of thumb", was getting stuck in the hole. The intestine was not damaged. The surgeon peeled and removed the mesh from the site. The site was treated by manual suturing. The patient is currently in good condition.
 
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 avenue
north haven, CT 06473
2034925563
MDR Report Key6569119
MDR Text Key109543448
Report Number9615742-2017-05127
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberSYM2015OS
Device Catalogue NumberSYM2015OS
Device Lot NumberPPG0745X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2015
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: 05/16/2017 Patient Sequence Number: 1
-
-