BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 22352456 · Received June 27, 2025

    Report

    Report Number
    3010024164-2025-00001
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 27, 2025
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY RECOR AND THE INVESTIGATION CONFIRMED THAT ONE SIDE OF THE DEVICE PACKAGE WAS OPEN AND HAD NOT BEEN SEALED. THE INVESTIGATION IDENTIFIED THIS AS A SINGULAR EVENT.

    Description of Event or Problem · 0

    DURING PREPARATION FOR A PROCEDURE, THE DEVICE OUTER BOX WAS OPENED AND IT WAS DISCOVERED THAT ONE END OF THE PACKAGE SEAL CONTAINING THE DEVICE WAS MISSING (UNSEALED) BEFORE THE DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939089 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM CONNECTION CABLE QYI RECOR MEDICAL, INC. M4230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown