BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURO SPORT ADJUSTABLE KNEE BRACE

    MDR report key: 1872782 · Received October 12, 2010

    Report

    Report Number
    2110898-2010-00109
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    August 18, 2010
    Report Date
    October 8, 2010
    Manufacturer
    3M COMPANY, 3M CONSUMER HEALTH CARE
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRODUCT WAS AN SPORT ADJUSTABLE KNEE SUPPORT. CUSTOMER USED PRODUCT ON RIGHT KNEE. CUSTOMER STATED BRACE WAS WORN FOR ABOUT 8 HOURS. CUSTOMER NOTICED THE FOLLOWING DAY THAT THE AREA HAD BROKEN OUT AND WAS RED AND BUMPY. SHE STATED, SHE SAW HER DOCTOR AND THE DOCTOR GAVE HER AN ANTIBIOTIC. SHE HAS BEEN USING BENADRYL. CUSTOMER STATED AREA IS STILL DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURO SPORT ADJUSTABLE KNEE BRACE 890.3475 LIMB ORTHOSIS IQI 3M COMPANY, 3M CONSUMER HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization