COOK * DKBL-20-9.0-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-06 for COOK * DKBL-20-9.0-1 manufactured by Cook, Inc..

Event Text Entries

[497766] After complaints of pain, inflammation, and discoloration in pt's right breast, pt returned to surgery on 05/25/06 for removed of wire fragments from a needle localization wire that was used on 10/20/05 for a breast biopsy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number753495
MDR Report Key753495
Date Received2006-07-06
Date of Report2006-06-01
Date of Event2006-05-25
Date Facility Aware2006-05-25
Report Date2006-06-01
Date Reported to Mfgr2006-06-02
Date Added to Maude2006-08-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCOOK
Generic NameMODIFIED DISP KOPANS SPRING HOOK LOCALIZATION NEEDLE
Product CodeMIJ
Date Received2006-07-06
Model Number*
Catalog NumberDKBL-20-9.0-1
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key741304
ManufacturerCOOK, INC.
Manufacturer Address750 DANIELS WAY PO BOX 489 BLOOMINGTON IN 474020489 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-07-06

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