BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP DELTA

    MDR report key: 17410044 · Received July 27, 2023

    Report

    Report Number
    3012146457-2023-00005
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 24, 2023
    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

    THE LAST TREATMENT WAS ON (B)(6) 2023. THE PROBLEM WAS NOT REPORTED UNTIL ON (B)(6) 2023 THE WAS A BURN ON THE NECK, DUE TO THE HEADBAND NOT BEING USED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310782 DIGNICAP DELTA SCALP COOLING SYSTEM PMC DIGNITANA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other