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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
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2015
Event Type  malfunction  
Event Description
Complainant reported the silicone urinary catheter easily detaches from the device connector.The complainant further reported more than twenty product devices were affected but, the 'exact the number is unknown.'.
 
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 followup report will be submitted.Note: a separate 3500a form has been completed for the unknown number of devices associated with this complaint issue.Reported to the fda on 02/20/2015.
 
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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 2227 50
BO  222750
Manufacturer Contact
matthew walenciak
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4546675
MDR Text Key5517641
Report Number3007966929-2015-00027
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K896732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2015
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/29/2015
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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