BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 2511703 · Received March 14, 2012

    Report

    Report Number
    1314800-2012-00010
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 16, 2012
    Report Date
    March 12, 2012
    Manufacturer
    KAZ, INC
    Product Code
    FLL
    PMA / PMN Number
    K031928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE THERMOMETER WAS GIVING A ARTIFICIALLY HIGH READING. THE INACCURATE READING CAUSED AN UNNECESSARY TRIP TO THE DOCTOR. KAZ HAS REQUESTED THE THERMOMETER BACK FROM THE CONSUMER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN THERMOMETER FLL KAZ, INC IRT-4520 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other