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 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 158100410190
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported the urinometer did not drain at the connection between the foley catheter and the measuring chamber.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.
 
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, assoc director
211 american avenue
greensboro, NC 27409
9083779293
MDR Report Key4749165
MDR Text Key21547658
Report Number3007966929-2015-00044
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeCI
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 04/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number158100410190
Device Lot Number655189
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/23/2015
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
-
-