BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO PHOTAS CELLUMA DELUXE

    MDR report key: 14632949 · Received June 7, 2022

    Report

    Report Number
    MW5110184
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    December 12, 2021
    Report Date
    June 3, 2022
    Manufacturer
    BIOPHOTAS, INC.
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE USED THE CELLUMA DELUXE AS INSTRUCTED AND THE TREATMENT RESULTED IN PHOTODERMATITIS. WE IMMEDIATELY SENT THE PHOTOS TO BIO PHOTAS-CELLUMA. NO ASSISTANCE WAS OFFERED TO RETURN THE DEVICE OR RECEIVE A REFUND OF OUR MONIES. OUR PHYSICIAN SENT A LETTER STATING WE COULD NOT USE THE DEVICE AND INSTRUCTED IT SHOULD BE RETURNED. NO ASSISTANCE ONCE AGAIN FROM BIO PHOTAS-CELLUMA. WE CONTACTED BIO PHOTAS- CELLUMA ONCE AGAIN, YESTERDAY AFTER SPEAKING WITH THE FDA COMPLAINT DEPARTMENT OVER THE PHONE. WE REQUESTED THE MODEL NUMBER TO ALLOW THE FDA TO DO AN INVESTIGATION-AND WE DID RECEIVE THE DEVICE MODEL NUMBER THIS MORNING FROM BIO PHOTAS- CELLUMA-NOTHING MORE, ONLY THE MODEL NUMBER CDLX-001. TOTAL PAYMENT TO BIO PHOTAS- CELLUMA (B)(6) 2021. THANK YOU TO THE FDA FOR ASSISTING US AND MANY OTHER CONSUMERS OVER THE YEARS, WE ARE EXTREMELY APPRECIATIVE! FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324731 BIO PHOTAS CELLUMA DELUXE LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS BIOPHOTAS, INC. CDLX-001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female