BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMOENA

    MDR report key: 302753 · Received October 24, 2000

    Report

    Report Number
    MW1020298
    Event Type
    Injury
    Date Received
    October 24, 2000
    Date of Event
    January 11, 2000
    Report Date
    October 23, 2000
    Manufacturer
    COLOPLAST
    Product Code
    KCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STARTED HAVING CHILLS. WENT TO BED AND WOKE UP FEELING TERRIBLE. CHILD CAME AT 3 AND NOTICED RPTR HAD A BAD RED RASH ON CHEST WHERE BREAST WAS REMOVED. CALLED THE DR AND IT TOOK UP TO ABOUT AN HR TO GET THERE. THE NURSE MET RPTR AND SENT RPTR DIRECTLY TO ER. RPTR WAS ADMITTED TO HOSP AND WAS DIAGNOSED WITH CELLULITIS. THIS CAUSED RPTR TO GO INTO SEPTIC SHOCK. RPTR THINKS THE AMOENA PROSTHESIS CAUSED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMOENA SELF-ADHESIVE EXTERNAL KCZ COLOPLAST 880-8R *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L