BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP

    MDR report key: 18492032 · Received January 11, 2024

    Report

    Report Number
    3012146457-2024-00002
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 10, 2024
    Manufacturer
    DIGNITANA INC.
    Product Code
    PMC
    PMA / PMN Number
    K19111466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BURN ON THE FOREHEAD AT HAIRLINE. PATIENT DID NOT WEAR THE HEADBAND AS INSTRUCTIONS DIRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115147 DIGNICAP SCALP COOOLING PMC DIGNITANA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other