BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP DELTA

    MDR report key: 15179293 · Received August 5, 2022

    Report

    Report Number
    3012146457-2022-00003
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    July 25, 2022
    Report Date
    July 29, 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

    BURN ON THE NECK, PATIENT ERROR OR HEADBAND SLIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433850 DIGNICAP DELTA SCALP COOLING SYSTEM, PRODUCT CODE:PMC PMC DIGNITANA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown