URINE METER 158101310190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-18 for URINE METER 158101310190 manufactured by Unomedical Zavodskaya Street 50.

MAUDE Entry Details

Report Number3007966929-2019-00021
MDR Report Key8707947
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-06-18
Date Mfgr Received2019-05-30
Date Added to Maude2019-06-18
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 ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1UNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer StreetFE UNOMEDICAL LTD MINSK REGION
Manufacturer CityMINSKAYA VOBLASTS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURINE METER
Generic NameDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Product CodeFFG
Date Received2019-06-18
Model Number158101310190
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer AddressFE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-18

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