UNOMETER SAFETI PLUS - WITH LUER LOCK AND LUER 158101310190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-01-16 for UNOMETER SAFETI PLUS - WITH LUER LOCK AND LUER 158101310190 manufactured by Unomedical Ltd..

Event Text Entries

[5419753] It was reported the urinometer was attached to the patient's catheter; when the patient was turned, approximately 2 hours later, the nurse noted the urinometer had become detached from the catheter. As a result, the patient's bed linens were wet. The urinometer was discontinued at that time and replaced with a leg bag.
Patient Sequence No: 1, Text Type: D, B5


[12926103] Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. No additional patient/event details were available at the time of this report. Should additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007966929-2015-00020
MDR Report Key4432402
Report Source01,05,06
Date Received2015-01-16
Date of Report2015-01-05
Date of Event2014-12-23
Date Mfgr Received2015-01-05
Device Manufacturer Date2014-09-01
Date Added to Maude2015-02-05
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, INTERIM ASSOC.
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 AND LUER
Generic NameURINOMETER, MECHANICAL
Product CodeEXR
Date Received2015-01-16
Model Number158101310190
Lot Number170548
Device Expiration Date2019-08-01
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 222750 BO 222750


Patients

Patient NumberTreatmentOutcomeDate
10 2015-01-16

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