MalfunctionEXR
UNOMETER 500 - URINEMETERS
Received Dec 3, 2014 · Event occurred Oct 28, 2014
Report 3007966929-2014-00106 · MDR key 4320103
Device
Product problems
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE A TOTAL OF NINE (9) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE NINE SEPARATE 3500A FORMS HAVE BEEN GENERATED TO ADDRESS THE OTHER CASES. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE HEALTHCARE PROFESSIONAL STATED THE BURETTE CONTENTS DRAINED VERY SLOWLY - ALMOST AT A 'TRICKILE' PACE.