BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOVERA GEN 2

    MDR report key: 16447075 · Received February 24, 2023

    Report

    Report Number
    MW5115249
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    February 21, 2023
    Report Date
    February 22, 2023
    Manufacturer
    PACIRA PHARMACEUTICALS, INC.
    Product Code
    GXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PATIENT'S IOVERA TREATMENT (WITH GEN 2), WHEN HAND PIECE WAS BEING USED WITH A NEW NITROUS OXIDE CARTRIDGE, THE TREATMENT SITE GOT COLDER THAN NORMAL AND CAUSED THE SKIN TO FREEZE, RESULTING IN FREEZER BURN. THE AFFECTED AREA IS NO LARGER THAN A DIME, HOWEVER WILL RESULT IN SCABBING. PATIENT WAS MADE AWARE OF THIS REACTION AND ADVISED TO MAINTAIN COMMUNICATION WHILE THE TREATMENT SITE HEALS. WHEN REPORTED TO MANUFACTURE REP, IT WAS NOTED THAT THIS WAS A KNOWN ISSUE AND WAS STATED TO BE A "PROGRAMMING ISSUE WITH THE GEN 2 DEVICE. SHOULD BE RESOLVED IN NEXT FEW WEEKS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381590 IOVERA GEN 2 DEVICE, SURGICAL, CRYOGENIC GXH PACIRA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other