BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALDAHOL ACTIVATOR

    MDR report key: 1983726 · Received February 7, 2011

    Report

    Report Number
    MW5019334
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ALDEN MEDICAL LLC
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIRST NOTED ON (B)(6) 2011, WHAT APPEARED TO BE LARGE "CRYSTALS" DEPOSITING IN THE DRAINS OF OUR DISINFECTING PROCESSORS. ALDAHOL, THE HIGH LEVEL DISINFECTANT REQUIRED BY THE MFR, WAS CHANGED. FURTHER INVESTIGATION REVEALED THAT THE ALDAHOL ACTIVATOR BOTTLES ALL CONTAINED LARGE "CRYSTAL" FORMATIONS. ALL SUBSEQUENT SHIPMENTS TO DATE ARE NOTED TO CONTAIN THESE LARGE, YET VARYING IN DESCRIPTION "CRYSTALS." DATES OF USE: (B)(6) 2011 -CURRENTLY USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALDAHOL ACTIVATOR ALDAHOL ACTIVATOR MED ALDEN MEDICAL LLC 2710113
    2 ALDAHOL ACTIVATOR ALDAHOL ACTIVATOR MED ALDEN MEDICAL LLC 2710114

    Patients

    Seq Age Sex Outcome Treatment
    1