MalfunctionEXR
UNOMETER DAFETI PLUS - WITH LUER-LOCK
Received Jan 12, 2015 · Event occurred Dec 1, 2014
Report 3007966929-2015-00015 · MDR key 4425997
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
161114
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS "LEAKAGE BETWEEN THE CHAMBER AND THE BAG."
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADD'L INFO REQUESTED BUT, NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).