• 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 158100510190
Device Problems Leak/Splash (1354); Unable to Obtain Readings (1516); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2015
Event Type  malfunction  
Event Description
The nurse reports the unometer safeti open/close lever is in the closed position (in order to measure urine output) however, after one hour it is observed the measurement chamber is empty; urine flows into the collection bag making it impossible to obtain the urine measurement.
 
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.No further information was available at this time of the report.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.This complaint involves two devices, therefore a separate fda form 3500a will be drafted for each device.
 
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 reg, minskaya 22275 0
BO  222750
Manufacturer Contact
matthew walenciak, director
211 american avenue
greensboro, NC 27409
9083779293
MDR Report Key4817924
MDR Text Key16467340
Report Number3007966929-2015-00051
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K896732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/20/2015
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 Number158100510190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2015
Initial Date FDA Received06/03/2015
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
-
-