BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEAM STERILIZER

    MDR report key: 128301 · Received October 23, 1997

    Report

    Report Number
    2515984-1997-00005
    Event Type
    Death
    Date Received
    October 23, 1997
    Report Date
    October 22, 1997
    Manufacturer
    JOSLYN STERILIZER CORP.
    Product Code
    FLE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS ADMITTED TO AMBULATORY SURGERY CENTER FOR A HERNIA, AND A KNEE OPERATION ON A THURSDAY (DATE HAS NOT BEEN PROVIDED). THE FOLLOWING EVENT OCCURRED AFTER REMOVAL OF WIRES FROM THE PT'S KNEE. PT WAS READMITTED WITH A FEVER AND COMPLAINTS OF PRESSURE IN THE KNEE. THE PT EXPERIENCED KIDNEY FAILURE, AND DIED ON A SUNDAY (DATE NOT PROVIDED). PT WAS DIAGNOSED AS HAVING A FLESH EATING DISEASE. SERIAL NUMBER, DATE OF THE EVENT, AND OTHER INFO HAS BEEN REQUESTED, BUT AMBULATORY SURGERY CENTER HAS NOT RELEASED THIS INFO. CO'S PRODUCT HAS NOT BEEN POSITIVELY LINKED TO THIS EVENT. THIS REPORT IS SUBMITTED BECAUSE CO DOES NOT HAVE CONCLUSIVE EVIDENCE THAT ONE OF THE CO'S STERILIZERS WAS INVOLVED WITH THIS EVENT. RPTR HAS FOUR JOSLYN STERILIZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEAM STERILIZER STERILIZER FLE JOSLYN STERILIZER CORP. 1626 OR 2038 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death