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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500; URINOMETER, MECHANICAL
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UNOMEDICAL LTD. UNOMETER 500; URINOMETER, MECHANICAL Back to Search Results
Model Number 25104742
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported there was a hair inside the urinometer's sealed packaging.The urinometer was not used.
 
Manufacturer Narrative
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.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
UNOMETER 500
Type of Device
URINOMETER, MECHANICAL
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street
50 fanipol dzerzhinsk district
minsk region, minskaya voblasts
BO 
Manufacturer Contact
matthew walenciak, director
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4523985
MDR Text Key16174252
Report Number3007966929-2015-00026
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
PMA/PMN Number
K896732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/01/2019
Device Model Number25104742
Device Lot Number174650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
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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