BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRAMER FOLEY TRAY

    MDR report key: 744474 · Received June 22, 2005

    Report

    Report Number
    9612030-2005-00013
    Date Received
    June 22, 2005
    Date of Event
    May 29, 2005
    Report Date
    June 21, 2005
    Manufacturer
    KENMEX
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/DENDALL ON JUNE 21, 2005 THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. ACCORDING TO THE CUSTOMER "IN 2005, A PATIENT HAD BALLOON THAT WOULD NOT DEFLATE, UROLOGIST HAD TO POP THE BALLOON TO HAVE IT REMOVED. " NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMER FOLEY TRAY FOLEY CATHETER EZL KENMEX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other