UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-04-23 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER manufactured by Unomedical Ltd..

Event Text Entries

[18025059] It was reported the 'lack of hooks' on the urinometer 'generated instability in the ubication of the device allowing oscillation movements and a lack of control of the liquids due to the mobility of th urine'. No patient consequences were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[18165289] Based on the available information, this event is deemed a reportable malfunction. There was no reports of the patient being harmed as a result of this malfunction. Additional patient and event details have been requested. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007966929-2015-00041
MDR Report Key4726812
Report Source01,05,07
Date Received2015-04-23
Date of Report2015-04-08
Date of Event2015-04-07
Date Mfgr Received2015-04-08
Date Added to Maude2015-06-06
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 AVE.
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 Received2015-04-23
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 REGION MINSKAYA VOBLASTS 222750 BO 222750


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-23

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