BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECELL GO

    MDR report key: 20334721 · Received September 27, 2024

    Report

    Report Number
    MW5160280
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 26, 2024
    Manufacturer
    AVITA MEDICAL AMERICAS LLC.
    Product Code
    QCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE REPORTER CALLED REGARDING RECELL GO SKIN GRAFT DEVICE BY MANUFACTURER AVITA. THE REPORTER MENTIONED THE DEVICE IS NOT WORKING PROPERLY. ONE OF THE CONSUMER HAD TO UNDERGO PAIN DUE TO DEVICE MALFUNCTION WHICH MAY LEAD TO RISK FOR INFECTION. THE REPORTER HAS CONTACTED THE MANUFACTURER BUT HAS NOT RECEIVED ANY POSITIVE RESPONSE REGARDING TO RECALL THE DEVICE. THE DEVICE IS RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585268 RECELL GO MECHANICAL AND ENZYMATIC AUTOLOGOUS SKIN PROCESSOR FOR CELL SUSPENSION, WITH APP QCZ AVITA MEDICAL AMERICAS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other