CODMAN DISPOSABLE VEIN STRIPER 63-4031

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 2005-09-21 for CODMAN DISPOSABLE VEIN STRIPER 63-4031 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[386874] Customer reported two events in which the vein stripper broke in the pt during a vein stripper procedure. The surgeon was required to make a 1/2" incision to remove the broken portion. See mtg medwatch report# 1226348-2005-00221 for the first event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2005-00222
MDR Report Key636287
Report Source06
Date Received2005-09-21
Date Mfgr Received2005-08-25
Date Added to Maude2005-09-23
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 DRIVE
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 STRIPER
Generic NameSTRIPPER, VEIN, STRIPPER
Product CodeGAJ
Date Received2005-09-21
Model NumberNA
Catalog Number63-4031
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key625826
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 2005-09-21

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