BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIONIC SHOES

    MDR report key: 6947538 · Received October 13, 2017

    Report

    Report Number
    MW5072743
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    January 19, 2017
    Report Date
    October 10, 2017
    Manufacturer
    VIONIC
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED TWO PAIRS OF VIONIC SNEAKERS FROM (B)(6). ON (B)(6) 2017 I TRIED THEM ON TO MAKE SURE I LIKED THE FIT. THEY DID NOT FEEL RIGHT ON MY FOOT. I DECIDED TO WEAR THEM TO THE GROCERY - IT WOULD BE QUICK AND MAYBE COULD TELL MORE ABOUT THE SHOES. I WALKED FROM THE GROCERY STORE PARKING LOT WHICH IS SMALL AND BEFORE I WAS HALF WAY INTO THE STORE I HAD PAIN IN MY LEFT ANKLE AND MY LEFT KNEE POPPED, MY RIGHT KNEE HAD TERRIBLE PAIN TOO BUT DID NOT POP. I WAS HANGING ONTO THE SHELVING TO NOT FALL DOWN WHICH DREW THE ATTENTION FROM OTHER SHOPPERS. I NEEDED HELP AND RODE AN ELECTRIC CART TO MY CAR. AT THIS POINT IT HAD NOT BEEN 20 MINUTES SINCE PUTTING THE SHOES ON AT HOME. I HAD THE MAN THAT MAKES CUSTOM PRESCRIPTION ORTHOTICS LOOK AT THE SHOES COMPARING THEM TO ANOTHER PAIR OF VIONIC. SHOES I HAVE. HE CONCLUDED THE SHOES WERE ONE SIZE SMALLER THAN MARKED AND THIS PUT THE ARCH SUPPORT ON THE ORTHOTIC FOOTBED TO BE LOCATED BEHIND MY ARCH CAUSING MY ANKLE/FOOT TO ROTATE/ROLL TO THE OUTSIDE OF MY BODY. THE RIGHT SHOE ON BOTH PAIRS WERE DISTORTED IN A TWIST CAUSING THE SOLE TO WOBBLE FRONT TO BACK. I SAW A GENERAL PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729549 VIONIC SHOES ORTHOSIS, CORRECTIVE SHOE KNP VIONIC 335ADLEY/ASR-1437 LC: 10-26-16
    729550 VIONIC SHOES ORTHOSIS, CORRECTIVE SHOE KNP VIONIC 335ADLEY/ASR-1437

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability