UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Apr 23, 2015 · Event occurred Apr 7, 2015
Report 3007966929-2015-00041 · MDR key 4726812
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Product problems
- Defective Component
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE 'LACK OF HOOKS' ON THE URINOMETER 'GENERATED INSTABILITY IN THE UBICATION OF THE DEVICE ALLOWING OSCILLATION MOVEMENTS AND A LACK OF CONTROL OF THE LIQUIDS DUE TO THE MOBILITY OF TH URINE'. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).