BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURO BRAND SPORT HINGED KNEE BRACE

    MDR report key: 2860266 · Received November 9, 2012

    Report

    Report Number
    2110898-2012-00054
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 7, 2012
    Manufacturer
    3M CONSUMER HEALTH CARE
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. RESULTS: PRODUCT WAS NOT RETURNED FOR EVALUATION. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    HE WORE THE BRACE DURING THE DAY FOR ONE OR TWO DAYS. HE NOTICED RED AND ITCHING SKIN UNDERNEATH THE BRACE. THE REDNESS WORSENED TO RAISED SORES (NOT OPEN) AND THEY CONTINUED TO ITCH. STOPPED WEARING THE BRACE AND TRIED LOTION. HE WENT TO A DERMATOLOGIST WHO PRESCRIBED TRIAMCINOLONE ACETONIDE OINTMENT. HE IS GETTING BETTER AND NOT WORRIED ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURO BRAND SPORT HINGED KNEE BRACE 890.3475 LIMB ORTHOSIS ITQ 3M CONSUMER HEALTH CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention