FLEXOR URETERAL ACCESS SHEATH AND DILATORS G46168 FUS-120045

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-07-22 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS G46168 FUS-120045 manufactured by Cook Inc.

MAUDE Entry Details

Report Number1820334-2019-01752
MDR Report Key8812985
Report SourceFOREIGN
Date Received2019-07-22
Date of Report2019-09-13
Date of Event2019-07-05
Date Mfgr Received2019-09-05
Device Manufacturer Date2018-11-29
Date Added to Maude2019-07-22
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 NameFLEXOR URETERAL ACCESS SHEATH AND DILATORS
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2019-07-22
Returned To Mfg2019-07-24
Model NumberG46168
Catalog NumberFUS-120045
Lot Number9343418
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 2019-07-22

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