BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HY-TAPE

    MDR report key: 19613060 · Received June 26, 2024

    Report

    Report Number
    19613060
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 2, 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

    HY-TAPE PRODUCT HAS BEEN FOUND TO BE DETACHING FROM THE ADHESIVE WHILE NEW IN THE BOX. NEONATE INTENSIVE CARE UNIT (NICU) RESPIRATORY THERAPY (RT) TEAM COLLECTED ALL OF THE HY-TAPE THAT WERE STARTING TO GET STICKY/DEFECTIVE IN APPEARANCE. A LOT OF THE BOXES HAD THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674336 HY-TAPE TAPE AND BANDAGE, ADHESIVE KGX HY-TAPE INTERNATIONAL, INC. 7656107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown