BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 9616415 · Received January 22, 2020

    Report

    Report Number
    2032864-2020-00001
    Event Type
    Injury
    Date Received
    January 22, 2020
    Report Date
    January 21, 2020
    Manufacturer
    RA MEDICAL SYSTEMS, INC.
    Product Code
    PDU
    PMA / PMN Number
    K170349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AN AV FISTULA/PERFORATION WAS REPORTED DURING A CONFERENCE PRESENTATION. IT WAS REPORTED TO BE RESOLVED QUICKLY. ADDITIONAL PATIENT AND PROCEDURAL INFORMATION HAS BEEN REQUESTED; A FOLLOW UP REPORT WILL BE FILED IF FURTHER INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81680 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. DABRA 101 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention