BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMOENA

    MDR report key: 303293 · Received November 3, 2000

    Report

    Report Number
    2125337-2000-00001
    Event Type
    Injury
    Date Received
    November 3, 2000
    Date of Event
    January 11, 2000
    Report Date
    September 25, 2000
    Manufacturer
    COLOPLAST CORP.
    Product Code
    KCZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGES IN 2000 THAT THEY STARTED HAVING CHILLS. THE COMPLAINANT'S RELATIVE ALLEGEDLY NOTICED COMPLAINANT HAD A RASH ON COMPLAINANT'S CHEST WHERE THEY HAD A MASTECTOMY. COMPLAINANT SAID COMPLAINANT WAS ADMITTED TO THE HOSP AND DIAGNOSED WITH CELLULITIS. COMPLAINANT ALLEGES THAT THIS CAUSED THE COMPLAINANT TO GO INTO SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMOENA LUXA CONTACT BREAST FORM KCZ COLOPLAST CORP. 880-8R NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L