BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP DELTA

    MDR report key: 15058448 · Received July 19, 2022

    Report

    Report Number
    3012146-2022-00001
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    March 23, 2022
    Report Date
    July 19, 2022
    Manufacturer
    DIGNITANA, INC.
    Product Code
    PMC
    PMA / PMN Number
    K191166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USE ERROR RESULTED IN FOREHEAD BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404886 DIGNICAP DELTA SCALP COOLING SYSTEM PMC DIGNITANA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown