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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL
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UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL Back to Search Results
Model Number 15810131019C
Device Problem Detachment Of Device Component (1104)
Patient Problem Not Applicable (3189)
Event Date 12/15/2014
Event Type  malfunction  
Event Description
It was reported while 'testing the device in the office to verify the resistance of the double lumen tube, part of the chamber of the unit broke free from the chamber immediately with low strength'.
 
Manufacturer Narrative
Based on the available info, this event is deemed a reportable malfunction.The device was not used on a patient.Should additional info become available, a f/u report will be submitted.(b)(4).
 
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Brand Name
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Type of Device
URINOMETER, MECHANICAL
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street
50 fanipol dzerzhinsk district
minsk region, minskaya voblasts 22275 0
BO  222750
Manufacturer Contact
matthew walenciak, dir
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4397568
MDR Text Key21838054
Report Number3007966929-2015-00003
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K896732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number15810131019C
Device Lot Number654188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/15/2014
Initial Date FDA Received01/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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