BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUELLER ADJUSTABLE ANKLE SUPPORT

    MDR report key: 5366379 · Received January 6, 2016

    Report

    Report Number
    2110420-2015-00001
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    December 11, 2015
    Report Date
    December 1, 2016
    Manufacturer
    MUELLER SPORTS MEDICINE, INC.
    Product Code
    ITW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4 ): 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. NUMBEROUS ATTEMPTS WERE MADE TO GATHER MORE INFORMATION FROM CONSUMER WITHOUT ANY SUCCESS. THIS ISSUE WILL BE MONITORED THROUGH THE COMPLAINTS AND CAPA SYSTEM WITHIN MUELLER'S QUALITY MANAGEMENT SYSTEM. COMPLAINT HAS BEEN CLOSED WITH NO FURTHER ACTION OR INVESTIGATION AT THIS TIME. CLASSIFICATION: CLASS I EXEMPT.

    Description of Event or Problem · 1

    CUSTOMER BOUGHT PRODUCT FROM (B)(6) BECAUSE THE CARTON SAID LATEX FREE MATERIALS. SHE WORE IT FOR 2 DAYS AND HAD AN EXTREME REACTION THAT IS SIMILAR TO THE ONE THAT SHE GETS FROM LATEX. NUMEROUS ATTEMPTS TO CONTACT CONSUMER DID NOT PRODUCE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8989 MUELLER ADJUSTABLE ANKLE SUPPORT ADJUSTABLE ANKLE SUPPORT ITW MUELLER SPORTS MEDICINE, INC. 4547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention