BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINPEN

    MDR report key: 15293343 · Received August 24, 2022

    Report

    Report Number
    MW5111704
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    March 17, 2022
    Report Date
    August 22, 2022
    Manufacturer
    CROWN LABORATORIES, INC.
    Product Code
    QAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED SKINPEN MICRONEEDLING TREATMENT WITH PRF INJECTIONS TO UPPER CHEEKS AND AROUND ORBITAL RIM AT (B)(6) IN (B)(6) FROM PROVIDER (B)(6). NOTICED TRAM TRACK SCARRING, ENLARGED PORES, CREPEY SKIN, AND OVERALL DEGRADATION OF SKIN TEXTURE, TONE, AND QUALITY ON DAY 4 POST TREATMENT, AFTER THE SWELLING SUBSIDED. I FOLLOWED AFTERCARE INSTRUCTIONS AND USED HG LIFT SKINFUSE HYDROGEL. IT IS CURRENTLY 5 MONTHS POST TREATMENT AND THE SCARRING, PORES, AND CRINKLY TEXTURE REMAIN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414335 SKINPEN POWERED MICRONEEDLE DEVICE QAI CROWN LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other FISH OIL| MELATONIN