BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGNICAP DELTA

    MDR report key: 10851549 · Received November 17, 2020

    Report

    Report Number
    10851549
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 15, 2020
    Manufacturer
    DIGNITANA INC
    Product Code
    PMC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS USING THE DIGNICAP SCALP COOLING SYSTEM DURING HER CHEMOTHERAPY TREATMENT ON HER VISIT DAY. SHE HAD BEEN USING THE DIGNICAP FOR PREVENTION OF HAIR LOSS FOR SEVERAL TREATMENTS. SHE REPORTS NOTHING UNUSUAL WITH THE TREATMENT ON HER VISIT DAY EXCEPT THAT LATER SHE HAD RUBBED HER FOREHEAD AND NOTICE THAT SKIN HAD PEELED OFF. SHE CAME IN FOR A FOLLOW-UP APPOINTMENT WITH DOCTOR ON A LATER DATE AND SHOWED US THE TWO AREAS TEMPLE AND FOREHEAD THAT WERE AFFECTED. SHE REPORTS NO BLISTERING JUST SKIN PEELING. SHE HAD PUT OINTMENT ON IT AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317159 DIGNICAP DELTA SCALP COOLING SYSTEM PMC DIGNITANA INC DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA Other