BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KT TAPE PRO

    MDR report key: 9706262 · Received February 12, 2020

    Report

    Report Number
    MW5092962
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    February 7, 2020
    Report Date
    February 9, 2020
    Manufacturer
    KT HEALTH, LLC.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLISTERS. WORE KT TAPE X 3 HOURS ON THURS (B)(6) 2020. REMOVED AND SHOWED AFTER PRACTICE. THE NEXT DAY THE AREA HAD EXTENSIVE BLISTERING. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? YES. QUANTITY: 2 STRIPS. FREQUENCY: DAILY. HOW WAS IT TAKEN OR USED: TOPICAL. DATE THE PERSON STARTED TAKING OR USING THE PRODUCT: (B)(6) 2020. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166860 KT TAPE PRO BANDAGE, ELASTIC FQM KT HEALTH, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other