BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFEPLACE INFANT SECURITY BAND

    MDR report key: 575858 · Received February 14, 2005

    Report

    Report Number
    575858
    Event Type
    Other
    Date Received
    February 14, 2005
    Date of Event
    January 12, 2005
    Report Date
    February 14, 2005
    Manufacturer
    RF TECHNOLOGIES, INC.
    Product Code
    KMI
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SAFEPLACE BAND ON THE PATIENT'S LEFT ANKLE WAS FOUND TO BE TOO TIGHT. THE FOOT STARTED TO SHOW SOME SWELLING. THE BAND WAS REMOVED AND A NEW SAFEPLACE BAND WAS PUT ON THE WRIST. THE EFFECTED EXTREMITY WAS ELEVATED AND WARM PACKS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFEPLACE INFANT SECURITY BAND ALARM BAND KMI RF TECHNOLOGIES, INC. UNK 041005-801

    Patients

    Seq Age Sex Outcome Treatment
    1 *