BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HY-TAPE

    MDR report key: 19613059 · Received June 26, 2024

    Report

    Report Number
    19613059
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 17, 2024
    Manufacturer
    HY-TAPE INTERNATIONAL, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PARENT WAS SKIN TO SKIN WITH THE INFANT, AND THE INFANT WAS NOTING TO BE DESATURATING INTO LOW 70'S/60'S. AFTER SUCTIONING THE TUBE PLACEMENT WAS CHECKED AND FOUND TO BE AT 5 INSTEAD OF 6. THE HY-TAPE LOOKED TO BE SPLIT/RIPPED ON THE LEFT SIDE AND REQUIRED RE-TAPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674335 HY-TAPE TAPE AND BANDAGE, ADHESIVE KGX HY-TAPE INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown