UNOMETER 500, URINE METER (WITH FIXED BAG AND
Received Jun 10, 2015
Report 3007966929-2015-00055 · MDR key 4837971
Device
Product problems
- Connection Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATIONAL WAS RECEIVED JUNE 09, 2015. THE LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JUNE 30, 2015.
Description of Event or Problem
IT WAS REPORTED THE URINOMETER DISCONNECTED FROM THE PATIENT'S CATHETER WHILE IN USE. THIS ISSUE OCCURRED AN UNKNOWN NUMBER OF TIMES WITH AN UNKNOWN NUMBER OF DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE 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.