BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRAMER FOLEY TRAY

    MDR report key: 744495 · Received June 22, 2005

    Report

    Report Number
    9612030-2005-00012
    Date Received
    June 22, 2005
    Date of Event
    May 25, 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/KENDALL ON JUNE 21, 2005 THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. ACCORDING TO THE CUSTOMER "THE BALLOON ON THE ULTRAMER CATHETER WOULD NOT DEFLATE. CATHETERS WERE TESTED PRIOR TO INSERTING INTO PATIENT. UROLOGIST HAD TO POP BALLOON TO REMOVE CATHETER." NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMER FOLEY TRAY FOLEY CATHETER 16 FR EZL KENMEX * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other