BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL COMPRESSION BAND PH BAND

    MDR report key: 18365309 · Received December 19, 2023

    Report

    Report Number
    MW5149398
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    December 4, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDICAL INGENUITIES, LLC
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RADIAL COMPRESSION DEVICE (PH BAND) LOST AIR UPON INFLATION. A LEAK WAS DETECTED AT THE JUNCTION OF A WELD PORTION OF THE BALLOON. THE DEVICE WAS REMOVED AND A SECOND PH BAND WAS APPLIED WITH NO FURTHER PROBLEMS. THERE WAS NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034649 RADIAL COMPRESSION BAND PH BAND CLAMP, VASCULAR DXC MEDICAL INGENUITIES, LLC 020588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown