BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIZONE VP4 STERILIZER

    MDR report key: 6734026 · Received July 21, 2017

    Report

    Report Number
    3011762828-2017-00002
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 21, 2017
    Report Date
    July 21, 2017
    Manufacturer
    TSO3 INC.
    Product Code
    PJJ
    UDI-DI
    00690455440003
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A USER OF THE DEVICE, UPON RELOADING A CART WHILE GETTING READY TO LOAD THE MACHINE, GOT A BURNING SENSATION COMING FROM UNDER THE GLOVES, REMOVED THEM AND WASHED HER HANDS. THERE WAS NO REPORT OF A MEDICAL EVALUATION OR MEDICAL TREATMENT ASSOCIATED WITH THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513762 STERIZONE VP4 STERILIZER TWO OR MORE STERILANT STERILIZER PJJ TSO3 INC. 44000-R NA 00690455440003

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other