BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOC BAND

    MDR report key: 170694 · Received June 2, 1998

    Report

    Report Number
    MW1013901
    Event Type
    Malfunction
    Date Received
    June 2, 1998
    Report Date
    June 2, 1998
    Manufacturer
    CRANIAL THERAPIES, INC.
    Product Code
    IQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE RPTR'S CALL WAS PROMPTED BY AN ADVERTISEMENT SHE SAW IN A MAGAZINE. THE RPTR IS NOT CALLING IN AN OFFICIAL CAPACITY. WHILE AT A CONFERENCE IN LOS ANGELES, THE RPTR SAW THE ADVERTISEMENT FOR DOC BAND IN A LOCAL PARENT'S MAGAZINE. THE RPTR HAD CONCERNS AS TO SAFETY OF THE DEVICE IN RELATION TO ITS INTENDED USE. THE ADVERTISED USE IS FOR CORRECTING THE MISSHAPEN HEADS OF CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOC BAND CRANIOPLASTY IQF CRANIAL THERAPIES, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA