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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
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UNOMEDICAL LTD. UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER Back to Search Results
Model Number 158101310190
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2015
Event Type  malfunction  
Event Description
It was reported the urine did not flow from the urinary catheter into the urinometer.The device was disconnected and replaced.No patient complications were reported.
 
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.This complaint involves five devices, therefore a separate fda form 3500a will be drafted for each device.
 
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Brand Name
UNOMETER SAFETI PLUS WITH LUER-LOCK & 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 Key4723521
MDR Text Key5580965
Report Number3007966929-2015-00039
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeIT
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 04/10/2015
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 Model Number158101310190
Device Lot Number181888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2015
Initial Date FDA Received04/22/2015
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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