BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURO NIGHT WRIST SLEEP SUPPORT ADJ

    MDR report key: 1958972 · Received January 7, 2011

    Report

    Report Number
    2110898-2011-00002
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    3M COMPANY, 3M CONSUMER HEALTH CARE
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO MANUFACTURER. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DEBBIE REPORTS THE FOLLOWING: BOUGHT A FEW MONTHS AGO. HAS NOTICED THAT OVER TIME, ON THE BASE OF HER HAND/THUMB, THE SKIN WAS ITCHING. THEN OVER THE MONTHS, IT GOT WORSE AND SHE WAS SCRATCHING IT AND THE SKIN STARTED PEELING. EVENTUALLY SHE WAS "LOOSING LAYERS OF SKIN." REACTION WAS ON BOTH HANDS, BOTH REACTING IN THE SAME WAY, SAME PLACES. BRACES WERE WORN ON BOTH HANDS EVERY NIGHT. THE BRACES ARE VERY HELPFUL. WHEN WORN AT NIGHT, HER HANDS DON'T HURT DURING THE DAYS SO SHE WANTS TO CONTINUE TO WEAR THEM. SHE WENT TO HER DERMATOLOGIST WHO GAVE HER A STEROID CREAM WHICH HELPED BUT NOT HEALED THE AREA. ANOTHER DERMATOLOGIST ADVISED THAT SHE WEAR COTTON GLOVES UNDER THE BRACES. THIS HELPS BUT STILL HAVING SOME ITCHING BUT THE IRRITATION IS LESS. SHE IS NOT SURE IF THE REACTION IS RELATED TO THE BRACES OR NOT. SHE REPORTS THAT SHE HAS MANY OTHER "SKIN ISSUES" AND HAD HAD IRRITATION FROM SHIRTS WORN TO BED AND OTHER FIBERS, BOTH NATURAL AND SYNTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURO NIGHT WRIST SLEEP SUPPORT ADJ 890.3475 LIMB ORTHOSIS IQI 3M COMPANY, 3M CONSUMER HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other