KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-11.0-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-17 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-11.0-A manufactured by Cook Inc.

Event Text Entries

[114148102] (b)(4). Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[114148103] It was reported during a breast localization procedure, a hair like "fibre" was found in an unopened kopans modified breast lesion localization needle pouch. Another device was used in the procedure. As reported, the device did not make patient contact; therefore, this device issue did not cause an adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-02086
MDR Report Key7693314
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-07-17
Date of Report2018-10-09
Date of Event2018-06-19
Date Mfgr Received2018-09-18
Device Manufacturer Date2015-12-29
Date Added to Maude2018-07-17
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 Location3
Manufacturer ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
Generic NameMIJ NEEDLE, TUMOR LOCALIZATION
Product CodeMIJ
Date Received2018-07-17
Returned To Mfg2018-08-14
Catalog NumberDKBL-20-11.0-A
Lot NumberNS6487651
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-17

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