BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURO ENERGIZING WRIST SUPPORT

    MDR report key: 1958927 · Received January 7, 2011

    Report

    Report Number
    2110898-2011-00003
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 26, 2010
    Manufacturer
    3M COMPANY, 3M CONSUMER HEALTH CARE
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    FUTURO ENERGIZING WRIST SUPPORT - NO LOT CODES FOR BRACES. CUSTOMER STATED SHE WORE THE WRIST BRACE FOR LESS THAN TWO SECONDS ON HER RIGHT WRIST AND IT CAUSED INCREDIBLE PAIN. SHE WORE THE BRACE ON (B)(6), FOR "TWO SECONDS", THEN REMOVED IT AFTER THE PAIN STARTED. PAIN REMAINED WHEN BRACE WAS REMOVED. SHE WENT TO THE DOCTOR ON (B)(6). CUSTOMER STATED HER DOCTOR TOLD HER THE METAL BAR IN THE BRACE PUSHED ON THE NERVES IN THE MIDDLE OF HER HAND, CAUSING THE INTENSE PAIN. THE DOCTOR PRESCRIBED PREDNISONE FOR THE PAIN. CUSTOMER WENT TO THE DOCTOR AGAIN ON (B)(6), AS A FOLLOW UP. TODAY SHE IS STILL ON "HEAVY PREDNISONE" FOR THE PAIN IN HER HAND. AGENT DID NOT ASK IF A DOCTOR PRESCRIBED THE USE OF A BRACE ON HER WRIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other