UNOMETER 500 - URINEMETERS
Received Dec 3, 2014 · Event occurred Oct 28, 2014
Report 3007966929-2014-00104 · MDR key 4320120
Device
Product problems
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE HEALTH CARE PROFESSIONAL STATED ONCE THE BURETTE WAS FILLED STAFF HAD DIFFICULTY DRAINING THE CONTENTS INTO THE END DRAINAGE BAG.
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.