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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS W/ LUER-LOCK & LUER-SLIP; URINOMETER, MECHANICAL
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UNOMEDICAL LTD. UNOMETER SAFETI PLUS W/ LUER-LOCK & LUER-SLIP; URINOMETER, MECHANICAL Back to Search Results
Model Number 158101210190
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
A nurse reported that the urine does not flow spontaneously without the manipulation of the circuit.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.
 
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Brand Name
UNOMETER SAFETI PLUS W/ LUER-LOCK & LUER-SLIP
Type of Device
URINOMETER, MECHANICAL
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya st., 50 fanipol dzerzhinsk district
minsk region
minskaya voblasts 22275 0
BO  222750
Manufacturer Contact
matthew walenciak
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4355761
MDR Text Key5221920
Report Number3007966929-2014-00133
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K896732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2019
Device Model Number158101210190
Device Lot Number154054
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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