BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LITTMANN ELECTRONIC STETHOSCOPE

    MDR report key: 3535739 · Received November 12, 2013

    Report

    Report Number
    2110898-2013-00071
    Event Type
    Other
    Date Received
    November 12, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 24, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    DQD
    PMA / PMN Number
    K050159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS NOT PROVIDED. DEVICE DOES NOT HAVE AN EXPIRATION DATE. ACTUAL USED DEVICE WAS NOT RETURNED. WITHOUT LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE. THIS PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE RESPIRATORY THERAPIST, WITH A SEVERE LATEX ALLERGY, REPORTED SHE USED A SOFT BLACK EAR TIP THAT SHE BORROWED FROM HER BOSS AFTER HER SOFT GREY EAR TIP SPLIT. REPORTEDLY, SHE CLEANED IT WITH ALCOHOL BEFORE USING IT ON HER SCOPE. THE USER USED IT IN A PATIENT'S ROOM AND HER EAR BECAME BEET RED, SWOLLEN, STARTED ITCHING AND THE REACTION SPREAD TO HER HEAD, FACE, AND ARM. REPORTEDLY WENT TO THE ER AND WAS TREATED WITH BENADRYL AND DECADRON (IM INJECTION) AND A VISTARIL PRESCRIPTION. USER STATED HER BOSS IS CURRENTLY USING THE BLACK EAR TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586349 3M LITTMANN ELECTRONIC STETHOSCOPE STETHOSCOPE, ELECTRONIC 870.1875 DQD DQD 3M HEALTH CARE 3100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other