• 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 PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL

  • 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 PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL Back to Search Results
Model Number 158101310190
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2015
Event Type  malfunction  
Event Description
The intensive care unit (icu) nurse reports the burette separated from the main collection chamber of the unometer safeti plus while the patient was being escorted from the bathroom and 'urine spilled over the floor and splashed onto the icu nurse who was escorting the patient.' the icu nurse further reports the unometer safeti plus was in place for two days when the burette separated from the main collection chamber.It was also reported that the device was removed from the patient and was replaced.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 22275 0
BO  222750
Manufacturer Contact
matthew walenciak
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4511145
MDR Text Key19499510
Report Number3007966929-2015-00025
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeAS
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 01/29/2015
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received02/11/2015
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
-
-