BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUELLER REVERSIBEL THUMB STABILIZER

    MDR report key: 5366371 · Received January 6, 2016

    Report

    Report Number
    2110420-2015-00002
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    June 18, 2015
    Report Date
    January 5, 2016
    Manufacturer
    MUELLER SPORTS MEDICINE, INC.
    Product Code
    ILH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MUELLER SPORTS MEDICINE HAS REPORTED THIS COMPLAINT VOLUNTARILY BASED ON THE ISSUE OF POTENTIAL SERIOUS INJURY THAT COULD HAVE BEEN THE RESULT OF THE PRODUCT COMING IN CONTACT WITH CONSUMERS SKIN CAUSING A SKIN REACTION. GOOD FAITH EFFORTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. MUELLER WILL SEND FOLLOW UP REPORT IF ADDITIONAL INPUT IS RECEIVED. THIS ISSUE WILL BE MONITORED THROUGH THE COMPLAINTS AND CAPA SYSTEM WITHIN MUELLER'S QUALITY MANAGEMENT SYSTEM. CLASSIFICATION: CLASS I EXEMPT.

    Description of Event or Problem · 1

    CONSUMER PURCHASED AT A (B)(6) AND HAD PRODUCT FOR APPROX 3 WEEKS. HE USED IT DAILY FROM 10PM TO 8 AM ACCORDING TO CONSUMER. HE HAD A REACTION AFTER WEARING THUMB STABILIZER AFTER ABOUT 3 TO 4 DAYS OF USE. HE STATED HE BROKE OUT IN A BAD RASH LOOKING LIKE POISON IVY OR OAK AND WENT TO A DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9053 MUELLER REVERSIBEL THUMB STABILIZER THUMB STABILIZER ILH MUELLER SPORTS MEDICINE, INC. 62712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1