BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREMIER UROSTOMY POUCH

    MDR report key: 515309 · Received March 2, 2004

    Report

    Report Number
    1921454-2004-00001
    Event Type
    Other
    Date Received
    March 2, 2004
    Date of Event
    January 28, 2004
    Report Date
    February 26, 2004
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER HAD AN ALLERGIC REACTION AFTER APPLYING DEVICE. AS A RESULT AN EPI-PEN AND TWO ALBUTEROL (BRONCHODILATOR) TREATMENTS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIER UROSTOMY POUCH UROSTOMY POUCH EXB HOLLISTER INCORPORATED NA 3J101

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other