BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICAP DELTA

    MDR report key: 17088945 · Received June 8, 2023

    Report

    Report Number
    3012146457-2023-00002
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 7, 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 NECK DUE TO HEADBAND NOT BEING IN THE CORRECT PLACE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267116 DIGNICAP DELTA SCALP COOLING SYSTEM,, PRODUCT CODE:PMC, PMC DIGNITANA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other