BEUDAMED
    FDA Adverse Event Other Summary report: N

    TR BAND RADIAL COMPRESSION DEVICE

    MDR report key: 21833908 · Received April 14, 2025

    Report

    Report Number
    MW5168982
    Event Type
    Other
    Date Received
    April 14, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 8, 2025
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DXC
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RADIAL BAND WAS PLACED AND AIR EXPELLED AS PER ORDER. RADIAL BAND WAS REMOVED AT 1545. AT 1650 PATIENT RADIAL SITE BEGAN TO BLEED PROFUSELY. RADIAL BAND TO BE APPLIED FOR 1 MORE HOUR AND AIR TITRATED AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270314 TR BAND RADIAL COMPRESSION DEVICE CLAMP, VASCULAR DXC TERUMO MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown