CODMAN DISPOS PERFORATOR 261221

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 2006-02-13 for CODMAN DISPOS PERFORATOR 261221 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[17017483] Customer reports that the perforator failed to disengage which perforated the dura. There was no additional harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2006-00336
MDR Report Key674137
Report Source06
Date Received2006-02-13
Date Mfgr Received2006-01-18
Date Added to Maude2006-02-15
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 StreetNEW BEDFORD INDUSTRIAL PARK
Manufacturer CityNEW BEDFORD MA 02745
Manufacturer CountryUS
Manufacturer Postal Code02745
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCODMAN DISPOS PERFORATOR
Generic NameDRILLS, BURRS, TREPHINES & ACC
Product CodeKAT
Date Received2006-02-13
Model NumberNA
Catalog Number261221
Lot NumberDX848
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key663418
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer AddressNEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US
Baseline Brand NameCODMAN DISPOS PERFORATOR
Baseline Generic NameDRILLS, BURRS, TREPHINES & ACC
Baseline Model NoNA
Baseline Catalog No261221
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-02-13

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