BEUDAMED
    FDA Adverse Event Summary report: N

    RUBBER ORTHODONTIC BAND

    MDR report key: 17185 · Received October 26, 1994

    Report

    Report Number
    MW1003825
    Date Received
    October 26, 1994
    Report Date
    September 28, 1994
    Manufacturer
    UNKNOWN
    Product Code
    ECI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR IS ALLERGIC TO LATEX. SHE DISCOVERED HER ALLERGY VIA THE USE OF RUBBER BANDS FOR ORTHODONTICS, A LATEX KNEE BRACE AND THE USE OF LATEX GLOVES. THE RUBBER BAND RESULTED IN MOUTH AND FACE SWELLING AND THE KNEE BRACE AND GLOVES RESULTED IN A SEVERE RASH. RPTR IS CONCERNED ABOUT HER ALLERGY BECAUSE SHE WORKS IN MEDICAL RESEARCH AND BECAUSE OF THE UNAVAILABILITY OF AN ALTERNATIVE TO LATEX CONDOMS FOR PROTECTION AGAINST HIV AND STDS. RPTR WAS NOT PREVIOUSLY ALLERGIC TO LATEX UNTIL AFTER PROLONGED ORTHODONTIC WORK. THE RUBBER BANDS ON HER BRACES WHEN SHE WAS 14 CAUSED THE ALLERGIC REACTION. (ALSO SEE 1003826 AND 1003827.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUBBER ORTHODONTIC BAND RUBBER BAND ECI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR