CODMAN DISPOS VEIN STRIP 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 2006-11-01 for CODMAN DISPOS VEIN STRIP 63-4031 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[17038252] Affiliate reports that the veinstripper has broken in the distal part. A part of the device has been lost in the patient. X-ray needed. Risk of new surgery. Additional info from affiliate explained that a new surgery may be required in the future and that the remainder of the device was discarded.
Patient Sequence No: 1, Text Type: D, B5


[17205816] It was communicated by the affiliate that the remainder of the device has been discarded. Without the device codman is unable to conduct a proper investigation. Since a lot number has been provided a review of the device history records will be performed. We anticipate that the review will confirm that the device conformed to all testing and manufacturing specifications. If anything other wise is noted a follow-up report will be filed. In addition, if and when a second surgery is performed to retrieve the product and if it returned for evaluation this complaint will be re-opened. Trends will be monitored for this and similar complaints. At the present time this complaint is considered to be closed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226348-2006-00295
MDR Report Key775175
Report Source01,07
Date Received2006-11-01
Date of Event2006-09-26
Date Mfgr Received2006-10-04
Date Added to Maude2006-11-02
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 DISPOS VEIN STRIP
Generic NameSTRIPPER, VEIN, DISPOSABLE
Product CodeGAJ
Date Received2006-11-01
Model NumberNA
Catalog Number63-4031
Lot NumberKX552
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key762955
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 2006-11-01

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