BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL COMPRESSION BAND PH BAND

    MDR report key: 18365427 · Received December 19, 2023

    Report

    Report Number
    MW5149401
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    December 5, 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
    *

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN EXPLAINED THAT UPON INFLATING THE PH BAND UPON THE PATIENTS ARM, THE VALVE LEAKED UPON REMOVING THE SYRINGE. A SECOND PH BAND WAS THEN APPLIED WITH NO FURTHER LOSS OF AIR. THERE WAS NO COMPLICATION OR ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035680 RADIAL COMPRESSION BAND PH BAND CLAMP, VASCULAR DXC MEDICAL INGENUITIES, LLC 020492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown