BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATHES3D

    MDR report key: 12335804 · Received August 18, 2021

    Report

    Report Number
    12335804
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    June 28, 2021
    Report Date
    August 10, 2021
    Manufacturer
    SHEATHING TECHNOLOGIES, INC.
    Product Code
    ITX
    UDI-DI
    10842418102085
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    SHEATHING TECHNOLOGIES, INC. SHEATHES3D ULTRASOUND ADHESIVE PATCH DOES NOT HAVE ADHESIVE /GEL, THEREFORE DOES NOT ADHERE TO THE US PROBE COVER. UNABLE TO USE PRODUCT AS INTENDED.

    Description of Event or Problem · 1

    SHEATHING TECHNOLOGIES, INC. SHEATHES3D ULTRASOUND ADHESIVE PATCH DOES NOT HAVE ADHESIVE /GEL, THEREFORE DOES NOT ADHERE TO THE US PROBE COVER. UNABLE TO USE PRODUCT AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234511 SHEATHES3D TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX SHEATHING TECHNOLOGIES, INC. ADH-35-4 SJ20-50 10842418102085

    Patients

    Seq Age Sex Outcome Treatment
    1