BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGNICAP DELTA

    MDR report key: 11103344 · Received December 31, 2020

    Report

    Report Number
    3012146457-2020-00002
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    July 16, 2020
    Report Date
    December 31, 2020
    Manufacturer
    DIGNITANA, INC
    Product Code
    PMC
    PMA / PMN Number
    K191166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEAD SIZE OF THE PATIENTS USING SCALP COOLING THERAPY CAN VARY AMONG OUTLIER DEMOGRAPHICS, WHICH IS WHY WE RECOMMEND WEARING A HEADBAND ALONG WITH THE COOLING WRAP. THIS WILL HELP AVOID ANY CONTACT THE COLD SURFACE OF THE COOLING WRAP AND THE SKIN. THIS ADVERSE EVENT COULD HAVE BEEN AVOIDED IF THE PATIENT HAD WON THE HEADBAND DURING THE TREATMENT. AFTER BECOMING AWARE OF THE EVENT, WE HAVE INTRODUCED SEVERAL MEASURES TO COUNTER THIS ISSUE WHICH INCLUDES REQUIREMENT TO WEAR HEADBANDS DURING THE SCALP COOLING SESSION INTRODUCING SMALLER WRAP TO USER FACILITIES FOR OUTLIER PATIENTS USER TRAINING ON APPLICATION OF THE COOLING WRAP AND REDUCING COOLING INTENSITY OF THE DEVICE IF PATIENT HAS ALREADY GONE THROUGH HEAVY ALOPECIA AND HAS EXPOSED BALD SPOTS.

    Description of Event or Problem · 1

    PATIENT RECEIVED SKIN DARKENING ON THE FOREHEAD AREA AFTER THE SCALP COOLING SESSION WITH (B)(4) DEVICE. WE BELIEVE THIS OCCURED DUE TO DIRECT CONTACT ESTABLISHING BETWEEN THE COLD SURFACE OF THE COOLING WRAP AND BARE SKIN AROUND THESE AREAS. UPON FURTHER INVESTIGATION THROUGH COMMUNICATION/INTERVIEWS, IT WAS FOUND THAT PATIENT HAD NOT WORN HEADBAND IN THEIR 1ST TREATMENT. THIS CAUSED THEIR FOREHEAD SKIN TO BE EXPOSED AND IN CONTACT WITH THE COLD SURFACE OF THE COOLING WRAP FOR THE DURATION OF THE SCALP COOLING SESSION CAUSING THE CRYOGENIC BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565005 DIGNICAP DELTA DIGNICAP DELTA SCALP COOLING SYSTEM PMC DIGNITANA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention