BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOVERA

    MDR report key: 12600294 · Received October 8, 2021

    Report

    Report Number
    3009131456-2021-00001
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    July 29, 2021
    Report Date
    October 7, 2021
    Manufacturer
    PACIRA PHARMACEUTICALS, INC
    Product Code
    GXH
    PMA / PMN Number
    K133453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED N2O CARTRIDGES FROM THE INITIAL REPORTING FACILITY WERE REMOVED BY THE PACIRA FIELD REPRESENTATIVE AND RETURNED TO PACIRA FOR EVALUATION AND INVESTIGATION. ADDITIONALLY, A PRODUCT HOLD FOR THE SPECIFIED LOT OF N2O CARTRIDGES WAS PUT IN PLACE PENDING THE RESULTS OF THE INVESTIGATION. THE REPORTED EVENT WITH THE CARTRIDGES WAS LIMITED TO THE REPORTING FACILITY. ADDITIONAL ACTIONS FOR THIS EVENT WILL INCLUDE A CAPA TO IDENTIFY THE ROOT CAUSE OF THE INCIDENT. THE EVENT OCCURRED POST-PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EVENT AND NO INJURY ASSOCIATED WITH THIS INCIDENT. MONITORING OF ANY RELATED COMPLAINTS IS ON-GOING AS PART OF THE POST-MARKET SURVEILLANCE ACTIVITIES FOR THE IOVERA SYSTEM.

    Description of Event or Problem · 1

    ON 16-SEP-2021, PACIRA PHARMACUETICALS (PACIRA) BECAME AWARE OF AN EVENT REPORTED BY A FACILITY TO THE FDA, THROUGH THE MEDWATCH PROGRAM, ON 26-AUG-2021. AS DESCRIBED IN THE MEDWATCH REPORT: MW5103601, AT THE END OF PROCEDURE WHERE AN IOVERA DEVICE HAD BEEN USED, THE PRESSURIZED CARTRIDGE DISLODGED FROM THE IOVERA DEVICE AND STRUCK A WALL IN THE PROCEDURE ROOM. THERE WERE NO INJURIES OR OTHER ADVERSE EVENTS AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499289 IOVERA CRYOGENIC SURGICAL DEVICE GXH PACIRA PHARMACEUTICALS, INC HPT0211 2101013

    Patients

    Seq Age Sex Outcome Treatment
    1