UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100510190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2015-06-03 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100510190 manufactured by Unomedical Ltd..

Event Text Entries

[16467340] The nurse reports the unometer safeti open/close lever is in the closed position (in order to measure urine output) however, after one hour it is observed the measurement chamber is empty; urine flows into the collection bag making it impossible to obtain the urine measurement.
Patient Sequence No: 1, Text Type: D, B5


[16765054] Based on the available information, this event is deemed a reportable malfunction. No further information was available at this time of the report. There were no reports of the patient being harmed as a result of this malfunction. Should additional information become available, a follow-up report will be submitted. This complaint involves two devices, therefore a separate fda form 3500a will be drafted for each device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007966929-2015-00051
MDR Report Key4817924
Report Source01,05,06,08
Date Received2015-06-03
Date of Report2015-05-20
Date of Event2015-05-05
Date Mfgr Received2015-05-20
Date Added to Maude2015-06-23
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 FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, DIRECTOR
Manufacturer Street211 AMERICAN AVENUE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Generic NameURINOMETER, MECHANICAL
Product CodeEXR
Date Received2015-06-03
Model Number158100510190
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL LTD.
Manufacturer AddressZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REG, MINSKAYA 222750 BO 222750


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-03

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