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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500 - URINEMETERS; URINE FLOW RATE MEASURING NON-ELECTR
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UNOMEDICAL LTD. UNOMETER 500 - URINEMETERS; URINE FLOW RATE MEASURING NON-ELECTR Back to Search Results
Model Number 158101310190
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2014
Event Type  malfunction  
Event Description
It was reported that the nurse found that the distal end of the drain tube that is normally fixed into the burette was actually dislodged allowing urine to drain freely onto floor.
 
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 500 - URINEMETERS
Type of Device
URINE FLOW RATE MEASURING NON-ELECTR
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street 50
50 fanipol dzerzhinsk district
minsk region, minskaya voblasts 22275 0
BO  222750
Manufacturer Contact
matthew walenciak, director
211 american avenue
greensboro, NC 27409
9083779293
MDR Report Key4425924
MDR Text Key5412915
Report Number3007966929-2015-00016
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2019
Device Model Number158101310190
Device Lot Number162015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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