BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGNICAP DELTA

    MDR report key: 11114056 · Received January 4, 2021

    Report

    Report Number
    3012146457-2020-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    November 29, 2019
    Report Date
    January 4, 2021
    Manufacturer
    DIGNITANA, INC.
    Product Code
    PMC
    PMA / PMN Number
    K191166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    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 BETWEEN THE COLD SURFACE OF THE COOLING WRAP AND THE SKIN. SOME OF THESE ADVERSE EVENT COULD HAVE BEEN AVOIDED IF THE PATIENT HAD WORN THE HEADBAND DURING THE TREATMENT. AFTER THE 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, EAR LOBES AND NAPE OF THE NECK REGION AFTER THE SCALP COOLING SESSION WITH DIGNICAP DELTA 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 THE PATIENT WAS AN OUTLIER IN TERMS OF HEAD SIZE, AND THE GENERAL SIZE OF THE COOLING WRAP WAS TOO BIG FOR THIS ONE PATIENT. THIS CAUSED THE EDGES OF THE SCALP AREA BE EXPOSED AND IN CONTACT WITH THE COLD SURFACE OF THE COOLING WRAP FOR THE DURATION OF THE SCALP COOLING SESSION CAUSING CRYPGENIC BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3603 DIGNICAP DELTA DIGNICAP DELTA SCALP COOLING SYSTEM PMC DIGNITANA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention