BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOVERA CARTRIDGE

    MDR report key: 12392130 · Received August 30, 2021

    Report

    Report Number
    MW5103601
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 26, 2021
    Manufacturer
    PACIRA PHARMACEUTICALS, INC.
    Product Code
    GXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARTRIDGE SHOT OFF THE END OF MACHINE. OCCURRED AT THE END OF PROCEDURE, CARTRIDGE TOP DISLODGED AND CARTRIDGE HIT WALL. THIS CARTRIDGE MISSED STAFF BY INCHES. WHILE USING THE LOVERA CYRO DEVICE DURING A CRYO BLOCK THE CARTRIDGE AT THE END OF THE BLOCK SHOT OFF THE END OF THE MACHINE. THE CARTRIDGE MISSED THE ANESTHESIOLOGIST'S HEAD BY INCHES AND THE PERIOPERATIVE NURSE BY A FOOT. DEVICE WAS SEQUESTERED AS WELL AS LOT NUMBERS ASSOCIATED WITH THE CARTRIDGE USED. REP WAS INFORMED AND REMOVED THOSE ITEMS ON 08/02/2021 FROM THE FACILITY AND SUPPLIED REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286101 LOVERA CARTRIDGE DEVICE, SURGICAL, CRYOGENIC GXH PACIRA PHARMACEUTICALS, INC. HPT0211

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other