BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP DELTA

    MDR report key: 22892519 · Received August 26, 2025

    Report

    Report Number
    3012146457-2025-00005
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 26, 2025
    Manufacturer
    DIGNITANA INC
    Product Code
    PMC
    UDI-DI
    00850036106005
    PMA / PMN Number
    K19111466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BURN ON THE TOP OF THE SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406130 DIGNICAP DELTA Scalp cooling system PMC DIGNITANA INC 900-1001 00850036106005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other