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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM2015
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2018
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, the defect size was a 5x7 cm epigastric hernia. Technology laparoscopic ipom. The surgeon used the device with reusable 10 mm trocar. The mesh was intact in the packaging. The collagen coating from the mesh was withered (dried out) and the shed remained in the packaging. The nurse cut the mesh dry on the corners and moistened it. The physician positioned it in the situs. He fixed first time the mesh with thread on the fascia. Shortly after began her the fixation with the abstack30 devices. Under the fixation detaches the sheathing from the mesh. The mesh was implant, despite damage of the mesh-coating. The mesh remained in the situs.

 
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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 Key7386936
MDR Text Key104039401
Report Number9615742-2018-00635
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/30/2018
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 HEALTH PROFESSIONAL
Device MODEL NumberSYM2015
Device Catalogue NumberSYM2015
Device LOT NumberPQL0842X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/08/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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