BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1071689 · Received July 9, 2008

    Report

    Report Number
    2084725-2008-00371
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 6, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER TOUCHED "SOMETHING WET" WHEN REMOVING THE POUCHES FROM THE CHAMBER. THE CUSTOMER EXPERIENCED "BURNING SENSATION" ON THEIR FINGERS AFTER THE WET SUBSTANCE DRIED. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO REMOVE THE SUBSTANCE BY FLUSHING COPIOUS AMOUNTS OF WATER. THE CUSTOMER HAD TO SCRAPE THE SKIN. THE BURNING SENSATION STILL REMAINED SHOUT ONE DAY. THE VAPORIZER PLATE WAS MISSING FROM THE MACHINE. IT WAS FOUND AND THAT THE FIELD ENGINEER HAD FORGOTTEN TO PUT THE VAPORIZER PLATE BACK AFTER SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK