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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD UM500 1500/2L/BO/ROH; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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UNOMEDICAL LTD UM500 1500/2L/BO/ROH; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE Back to Search Results
Model Number 25104742
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2013
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
It was reported that connector falls off tube, is broken.
 
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Brand Name
UM500 1500/2L/BO/ROH
Type of Device
DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Manufacturer (Section D)
UNOMEDICAL LTD
zavodskaya st 50
fanipol, dzerzhinsk/minsk 22275 0
BO  222750
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5153319
MDR Text Key28404053
Report Number3007966929-2015-30332
Device Sequence Number1
Product Code FFG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/01/2017
Device Model Number25104742
Device Lot Number650742
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
Was Device Evaluated by Manufacturer? Yes
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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