BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANITA

    MDR report key: 413660 · Received August 27, 2002

    Report

    Report Number
    MW1025989
    Event Type
    Malfunction
    Date Received
    August 27, 2002
    Report Date
    August 27, 2002
    Manufacturer
    TANITA CORP OF AMERICA
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BD-585 BABY SCALE HAS NO SIDE-WALLS OR END-WALLS. THE ADVERTISING BROCHURE STATES, IN FINE PRINT, "INFANTS SHOULD NEVER BE LEFT UNATTENDED ON SCALE". HOWEVER, RPTR IS AWARE OF THREE CASES IN WHICH INFANTS PUSHED DOWN WITH THEIR FEET AND SCOOTED HEAD-FIRST BACKWARDS OFF OF SIMILAR WEIGHT SCALES THAT HAD NO SIDEWALLS OR ENDWALLS. THESE INFANTS WERE NOT LEFT UNATTENDED. THE INFANTS DUG THEIR HEELS IN AND SCOOTED OFF THE END OF THE SCALE AND ONTO THE FLOOR BEFORE THE NURSE COULD CATCH THEM. ONE INFANT SUSTAINED AN INTRACRANIAL HEMORRHAGE. RPTR FEELS INFANT WEIGHT SCALES WITHOUT SIDEWALLS AND END-WALLS ARE DANGEROUS, EVEN IN THE PRESENCE OF AN ATTENDANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANITA INFANT WEIGHT SCALE FRW TANITA CORP OF AMERICA BD-585 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *