Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD UNOMETER SAFETI, 150CM, 2L,RH; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNOMEDICAL LTD UNOMETER SAFETI, 150CM, 2L,RH; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE Back to Search Results
Model Number 158101310190
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
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.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 the unometer was reported cracked.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNOMETER SAFETI, 150CM, 2L,RH
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 Key5152872
MDR Text Key28369944
Report Number3007966929-2015-30337
Device Sequence Number1
Product Code FFG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other
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 Date04/01/2019
Device Model Number158101310190
Device Lot Number158054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2014
Is the Reporter a Health Professional? No
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
-
-