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 05,06 report with the FDA on 2003-01-22 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[15035323] Tiny plastic cap on end of vein stripper broke off in vein during stripping procedure. Portion was retrieved and pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2003-00018
MDR Report Key439057
Report Source05,06
Date Received2003-01-22
Date of Report2002-12-23
Date of Event2002-12-20
Date Mfgr Received2002-12-23
Date Added to Maude2003-01-27
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 G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCODMAN DISPOSABLE VEIN STRIPPER
Generic NameSTRIPPER, VEIN, DISPOSABLE
Product CodeGAJ
Date Received2003-01-22
Returned To Mfg2003-01-10
Model NumberNA
Catalog Number63-4031
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key427993
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. Other 2003-01-22

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