BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP

    MDR report key: 17564162 · Received August 17, 2023

    Report

    Report Number
    3012146457-2023-00009
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 15, 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

    BURN ON THE NAPE OF THE NECK. PATIENT WORE HEADBAND BUT HAS VERY SHORT HAIR AND THE NAPE OF THE NECK WAS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246333 DIGNICAP SCALP COOLING PMC DIGNITANA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other