BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREENS BY ACE TEKZONE KNEE OPEN PAT

    MDR report key: 1872788 · Received October 12, 2010

    Report

    Report Number
    2110898-2010-00110
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    August 25, 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
    AZ, 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

    CUSTOMER REPORTS HIS RIGHT LEG BROKE OUT IN A RASH FROM WEARING A (B)(6) KNEE BRACE FOR ABOUT 8-10 HOURS. REPORTS HE REMOVED BEFORE BED AND THE NEXT MORNING, HE NOTICED A RASH THAT VARIED FROM WEEPING BLISTERS TO REDNESS AND SWELLING IN THE AREA WHERE THE BRACE TOUCHED HIS SKIN. HE TOOK A SHOWER AND APPLIED ANTI-ITCH CREAM. HE WENT TO THE DOCTOR WHO GAVE HIM A STEROID INJECTION AND AN ANTIBIOTIC PRESCRIPTION. CURRENTLY THE REACTION IS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALGREENS BY ACE TEKZONE KNEE OPEN PAT 890.3475 LIMB ORTHOSIS IQI 3M COMPANY, 3M CONSUMER HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization