inforMED
MalfunctionEXR

UNOMETER 500, URINE METER (WITH FIXED BAG AND

Received Jun 10, 2015

Report 3007966929-2015-00054 · MDR key 4837972

Device

Generic name

Urinometer, Mechanical

Manufacturer

Unomedical Ltd.

Model number

25039742

Product problems

  • Connection Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THE URINOMETER DISCONNECTED FROM THE PATIENT'S CATHETER WHILE IN USE. 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.