BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURO SPORT ADJ KNEE STABILIZER

    MDR report key: 2893202 · Received December 18, 2012

    Report

    Report Number
    2110898-2012-00070
    Event Type
    Other
    Date Received
    December 18, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 18, 2012
    Manufacturer
    3M COMPANY
    Product Code
    IQI
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN. MANUFACTURING SITE ADDRESS FOR DEVICE: FUSHING BROTHERS & CO., (B)(4)."

    Description of Event or Problem · 1

    CUSTOMER WORE THE FUTURO SPORT ADJUSTABLE KNEE STABILIZER ADJUSTABLE ON HIS RIGHT LEG AND BROKE OUT IN AN AWFUL RASH. BOUGHT BRACE ON (B)(6) AND WORE IT ON THE (B)(6) TO WORK. IT STARTED TO IRRITATE HIM AT ABOUT 3:30 THAT DAY. WHEN HE TOOK IT OFF AT 5:30, WHEN HE RETURNED FROM WORK, HIS KNEE WHERE THE BRACE TOUCHED WAS BLISTERED, RAW AND RED. IT ALSO WAS WEEPING AND RUNNING. WENT TO THE DOCTOR ON TUESDAY. THE DOCTOR PRESCRIBED. METHYLPREDNISOLONE AND CEPHALEXIN AND TOLD CUSTOMER TO WRAP HIS LEG IN GAUZE. TODAY HIS LEG IS GETTING BETTER BUT IS STILL RED AND SLIGHTLY WEEPING FROM BLISTERS. THE BRACE WAS TAKEN BACK TO (B)(6) AND WAS REIMBURSED FOR THE COST THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURO SPORT ADJ KNEE STABILIZER 890.3475 LIMB ORTHOSIS IQI 3M COMPANY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention