CODMAN DISPOSABLE VEIN STRIPPER 63-4031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-05-13 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[16362156] International affiliate reports that during the vein stripping operation, the cable broke and the strip remained in the vein of the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2004-00147
MDR Report Key524719
Report Source01,07
Date Received2004-05-13
Date of Report2004-04-16
Date Mfgr Received2004-04-16
Device Manufacturer Date2003-01-01
Date Added to Maude2004-05-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactMATTHEW KING
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088283106
Manufacturer G1CODMAN & SHURTLEFF, INC.
Manufacturer Street325 PARAMOUNT DR
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCODMAN DISPOSABLE VEIN STRIPPER
Generic NameSTRIPPER, VEIN, DISPOSABLE
Product CodeGAJ
Date Received2004-05-13
Model NumberNA
Catalog Number63-4031
Lot NumberAV542
ID NumberNA
Device Expiration Date2008-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key513847
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 02767 US
Baseline Brand NameCODMAN DISPOSABLE VEIN STRIPPER
Baseline Generic NameSTRIPPER, VEIN, DISPOSABLE
Baseline Model NoNA
Baseline Catalog No63-4031
Baseline IDNA
Baseline Device FamilyCODMAN DISPOSABLE VEIN STRIPPER
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]60
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2004-05-13

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