BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIZONE VP4 STERILIZER

    MDR report key: 6734048 · Received July 21, 2017

    Report

    Report Number
    3004148947-2017-00003
    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
    PMA / PMN Number
    K153689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ON THE DEVICE WAS CONDUCTED ON SITE BY SERVICE TECHNICIAN. ALL TEST VERIFICATIONS WERE PERFORMED AND THE UNIT MET MANUFACTURER SPECIFICATIONS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE ISSUE IS ASSOCIATED WITH THE USE OF THE DEVICE IN TERMS OF NON-CONFORMING TO THE DEVICE'S INSTRUCTIONS AND INFORMATION PROVIDED BY THE DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A USER OF THE DEVICE EXPERIENCED SLIGHT BURN/CHEMICAL IRRITATION ON HER HAND. THERE WAS NO REPORT OF A MEDICAL TREATMENT ASSOCIATED WITH THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513463 STERIZONE VP4 STERILIZER TWO OR MORE STERILANT STERILIZER PJJ TSO3 INC. 44000-R NA 00690455440003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other