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 W/ LUER-LOCK AND LUER-SLIP
  • 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 W/ LUER-LOCK AND LUER-SLIP Back to Search Results
Model Number 15810120190
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
A nurse reported that the urine does not flow spontaneously without the manipulation of the circuit.
 
Manufacturer Narrative
Based on the available info, this event is deemed to be a reportable malfunction.No additional pt/event details have been provided to date.Should additional info become available a follow up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNOMETER SAFETI PLUS W/ LUER-LOCK AND LUER-SLIP
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street 50
fanipol
dzerzhinsk district minsk region 00002 2275
BO  0000222750
Manufacturer Contact
matthew walenciak, assoc dir
211 american ave
greensboro, NC 27409-0000
9083779293
MDR Report Key4355742
MDR Text Key5141262
Report Number3007966929-2014-00132
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 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2019
Device Model Number15810120190
Device Lot Number154054
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-