BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8010478-2018-00005

    MDR report key: 8161565 · Received December 13, 2018

    Report

    Report Number
    8010478-2018-00005
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 14, 2018
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE FOLLOWING: THE INCIDENT WAS USER RELATED DUE TO A WRONG APPLICATION FROM THE CUSTOMER SITE. HE DID USE A PATHOLOGICAL TISSUE QUICK FREEZING SPRAY, NAMED WHITE FREEZER S, WHICH IS A FLAMMABLE SUBSTANCE, AND NOT RECOMMENDED FOR USE IN THE LEICA CM1950, ACCORDING TO THE INSTRUCTIONS FOR USE. A CUSTOMER FACING LETTER WILL BE SENT TO THE CUSTOMER WITH A RECOMMENDATION IN THE FUTURE NOT TO USE FLAMMABLE SUBSTANCES IN THE LEICA CM1950 WHEN IT IS TURNED ON AND PLUGGED IN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO LEICA BIOSYSTEMS THAT ON (B)(6) 2018 COMBUSTION WITH FIRE OCCURRED DURING THE USAGE OF AN INSTANT COOLING AGENT ON THE FREEZING SHELF IN THEIR CM1950. ON (B)(6) 2018 THE CUSTOMER INFORMED LEICA BIOSYSTEMS THAT HE WAS BURNED ON HIS ARM AND THE HAIR ON HIS FOREHEAD. HE WAS WEARING A MASK AND GOGGLES WHICH PREVENTED HIM FROM BEING BURNED ON HIS FACE. MEDICAL TREATMENT WAS NECESSARY.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other