BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOGEN SERIES

    MDR report key: 12575757 · Received October 5, 2021

    Report

    Report Number
    2954348-2021-00001
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    June 27, 2021
    Report Date
    September 3, 2021
    Manufacturer
    RST SANEXAS
    Product Code
    GZJ
    PMA / PMN Number
    K022433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS A USED SYSTEM PURCHASED FROM AN OUTSIDE SOURCE. DIAGNOSTICS AND TESTING WERE OFFERED TO VERIFY DEVICE FUNCTIONING APPROPRIATELY. CLIENT WANTED TO REPLACE ALL ACCESSORIES WITHOUT TESTING IN APRIL OF 2021. INVOICE WAS "TOO EXPENSIVE" AND THE ACCESSORIES WERE CANCELLED AND A REMINDER TO TEST THOSE ACCESSORIES PRIOR TO USE WAS GIVEN. ON AUGUST 5TH CLIENT CALLED TO REPLACE "DEFECTIVE" ACCESSORY. ON 8/6/2021 IT WAS DISCOVERED THE REPLACEMENT WAS DUE TO AN INJURY. IT WAS ESTABLISHED TESTING WAS NOT PROPERLY DONE AND THE ELECTRODE WAS NOT IN GOOD CONDITION. THE DEVICE FUNCTIONS AS INTENDED AND THERE ARE NO REPORTS OF ISSUES OUTSIDE THE ACCESSORY.

    Description of Event or Problem · 1

    PATIENT DEVELOPED BURN WOUND ON LEFT WRIST POST TREATMENT ON (B)(6) 2021. PATIENT EXPRESSED FEELING DISCOMFORT DURING TREATMENT AND INTENSITY LEVELS WERE ADJUSTED. PATIENT WAS REFERRED TO WOUND CARE CENTER. PATIENT PRESENTED WITH REDNESS AND BLISTERING. EXPERIENCED DISCOMFORT IN LEFT WRIST FOR A COUPLE WEEKS, NEEDED DRAINAGE, DRESSINGS AND ANTIBIOTICS. REPORTED AS DOING BETTER - (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471743 NEOGEN SERIES NEOGEN GZJ RST SANEXAS 1712

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention