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 05 report with the FDA on 2004-10-13 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[311180] It was reported that the vein stripper's head became disconnected from the cable while stripping the pt's vein. Fluoroscopy was required and an additional incision was made to retrieve the head.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2004-00314
MDR Report Key548209
Report Source05
Date Received2004-10-13
Date of Event2004-08-24
Date Mfgr Received2004-09-16
Date Added to Maude2004-10-14
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 DR
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 Received2004-10-13
Returned To Mfg2004-09-24
Model NumberNA
Catalog Number63-4031
Lot NumberLV544
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key537659
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 027670350 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 2004-10-13

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