TCI- TUMESCENT CATHETER INVERSION SYSTEM 7210023 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-03 for TCI- TUMESCENT CATHETER INVERSION SYSTEM 7210023 * manufactured by Smith & Nephew, Inc. - Endoscopy Division.

Event Text Entries

[520069] During a vein stripping procedure with the tci-tumescent catheter inversion system, the small green connector fell off and could not be found in the patient. X-ray did not show anything.
Patient Sequence No: 1, Text Type: D, B5


[7806614] Device was not returned for evaluation, therefore, no determination could be made for the reported device failure.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1216828-2006-00048
MDR Report Key778438
Report Source06
Date Received2006-11-03
Date of Report2006-11-03
Date of Event2006-09-29
Date Facility Aware2006-09-29
Report Date2006-11-03
Date Mfgr Received2006-10-04
Device Manufacturer Date2006-05-01
Date Added to Maude2006-11-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDONNA LANTEIGNE
Manufacturer Street150 MINUTEMAN RD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9787491576
Manufacturer G1SMITH & NEPHEW, INC
Manufacturer Street160 DASCOMB RD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTCI- TUMESCENT CATHETER INVERSION SYSTEM
Generic Name*
Product CodeGAJ
Date Received2006-11-03
Model Number7210023
Catalog Number*
Lot Number60850559
ID Number*
Device Expiration Date2009-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age4 MO
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key766211
ManufacturerSMITH & NEPHEW, INC. - ENDOSCOPY DIVISION
Manufacturer Address* ANDOVER MA * US
Baseline Brand NameTCI TUMESCENT CATHETER INVERSION SYSTEM
Baseline Generic Name*
Baseline Model No7210023
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2006-11-03

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