BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP DELTA

    MDR report key: 17072517 · Received June 6, 2023

    Report

    Report Number
    3012146457-2023-00001
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 6, 2023
    Manufacturer
    DIGNITANA INC.
    Product Code
    PMC
    PMA / PMN Number
    K191166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BURN ON FOREHEAD, HEADBAND NOT IN THE CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746168 DIGNICAP DELTA SCALP COOLING SYSTEM,, PRODUCT CODE:PMC PMC DIGNITANA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown