BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 2462032 · Received February 14, 2012

    Report

    Report Number
    1314800-2012-00003
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 8, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    103800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE THERMOMETER WAS READING INACCURATELY. SHE IS ALLEGING THE INACCURATE READING WAS THE CAUSE OF HER SON HAVING A SEIZURE WHICH REQUIRED A VISIT TO THE EMERGENCY ROOM. WE HAVE SENT A PRE-PAID LABEL TO THE CONSUMER FOR THE RETURN OF THE PRODUCT 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 UNKOWN Other