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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
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UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER Back to Search Results
Model Number 158100410190
Device Problem Restricted Flow rate (1248)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2015
Event Type  malfunction  
Event Description
It was reported 'the catheter that connected the foley catheter to the urinometer measuring chamber had to be manipulated to allow the urine flow'.No patient consequences were reported as a result of this event.
 
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.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street 50
fanipol
dzerzhinsk district minsk region 00002 2275
BO  0000222750
Manufacturer Contact
matthew walenciak, interim assoc.
211 american ave.
greensboro, NC 27409-0000
9083779293
MDR Report Key4810769
MDR Text Key5920123
Report Number3007966929-2015-00050
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 05/08/2015
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 Health Professional
Device Expiration Date06/01/2018
Device Model Number158100410190
Device Lot Number655189
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/08/2015
Initial Date FDA Received06/01/2015
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 Unknown
Patient Sequence Number1
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