BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESA INSOLES

    MDR report key: 7974478 · Received October 16, 2018

    Report

    Report Number
    MW5080620
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 6, 2018
    Report Date
    October 13, 2018
    Manufacturer
    RESA WEARABLES, INC.
    Product Code
    KYS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED INSOLE FROM A (B)(6) IN (B)(6) BECAUSE THE SALESPERSON INFORMED THERE'S AN ORTHOTIC MEDICAL DEVICE THAT WAS BETTER THAN THE ONE I WAS WEARING, AND I WOULD NOT NEED A PRESCRIPTION FOR IT. THEY STATED THEY WERE FDA APPROVED WHEN I ASKED THE YOUNG MAN. I TOOK THEM HOME AND TRIED FOR A WEEK AND MY FOOT BECAME NUMB. THE YOUNG MAN SAID THE SOFT INSOLE WAS FOR DIABETICS AND WOULD PREVENT NEUROPATHIC ISSUES IN MY FEET. I ONLY BOUGHT THEM BECAUSE OF THE CLAIMS MADE BY THE YOUNG MAN. I HAVE NOT FOUND ANY FDA INFO ABOUT THIS COMPANY. I THINK THEY ARE LYING ABOUT FDA APPROVAL AND TESTS BY THE FDA. I THINK THEY ARE SELLING A DANGEROUS PRODUCT. THE YOUNG MAN STATED IT WAS FDA TESTED AND APPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813095 RESA INSOLES INSOLES, MEDICAL KYS RESA WEARABLES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR