BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRX-T33 (MICRONEEDLING DEVICE)

    MDR report key: 22019259 · Received May 14, 2025

    Report

    Report Number
    MW5170347
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    November 26, 2024
    Report Date
    May 8, 2025
    Manufacturer
    DERMA PEN, LLC.
    Product Code
    QAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNDERWENT TWO COSMETIC PROCEDURES AT A PRIVATE CLINIC IN (B)(6) SPAIN, WHERE PRX-T33 WAS COMBINED WITH MICRONEEDLING (DERMAPEN) IN THE SAME SESSION AND APPLIED CONSECUTIVELY. IN BOTH CASES, THE ORDER WAS AS FOLLOWS: FIRST, DIRECT APPLICATION OF PRX-T33 ONTO THE SKIN, IMMEDIATELY FOLLOWED BY MICRONEEDLING. THIS SEQUENCE WAS REPEATED -- PRX-T33 FOLLOWED BY MICRONEEDLING -- WITH PARTICULAR EMPHASIS ON SENSITIVE AREAS SUCH AS THE ORBITAL CONTOUR OF THE EYES, LIPS, THE ENTIRE FACE, AND THE NECK. A THIRD APPLICATION OF PRX-T33 ALONE WAS THEN APPLIED AND LEFT ON THE SKIN "AS LONG AS I COULD TOLERATE," WHICH BECAME UNBEARABLE. I LEFT THE SESSION WITH MY FACE EXTREMELY RED. THE DÉCOLLETÉ WAS NOT TREATED, WHICH LATER CREATED A STARK CONTRAST BETWEEN THE DAMAGED AND UNTREATED AREAS. IN ALL SESSIONS, I WAS TOLD THAT TYPE 12 WATER WAS USED, WHICH MAY HAVE CONTRIBUTED TO THE AGGRESSIVENESS OF THE PROCEDURE. SINCE THEN, I HAVE EXPERIENCED SERIOUS ADVERSE EFFECTS. IN THE FIRST MONTHS: EXTREME REDNESS, INTENSE BURNING, AND CONSTANT DISCOMFORT. OVER TIME: PERSISTENT THINNING OF THE SKIN, LOSS OF ELASTICITY AND FIRMNESS, SAGGING, VISIBLE AGING, DULLNESS, PRONOUNCED DARK CIRCLES, INCREASED SENSITIVITY, AND A SUSPICIOUS OVAL MARK ABOVE THE UPPER LIP. I BELIEVE THAT THE COLLAGEN AND ELASTIN STRUCTURE OF MY SKIN HAS BEEN SIGNIFICANTLY DAMAGED. BEFORE THE TREATMENT, I HAD HEALTHY, FINE, AND WELL-CARED-FOR SKIN. I REPEATEDLY STATED THAT I DID NOT WANT ANY INVASIVE PROCEDURES, AS I HAD NEVER UNDERGONE SUCH TREATMENTS AND DID NOT BELIEVE I NEEDED THEM. I WAS NOT INFORMED OF THE INVASIVE AND AGGRESSIVE NATURE OF THE PROCEDURE, NO BASELINE PHOTOS WERE TAKEN, AND THE PROCEDURE WAS NOT PROPERLY DOCUMENTED. THE CLINIC NOW CLAIMS IT CANNOT ASSESS THE DAMAGE DUE TO THE ABSENCE OF PRE-TREATMENT PHOTOS. HOWEVER, I HAVE PHOTOS TAKEN TWO MONTHS BEFORE THE PROCEDURE, AS WELL AS VIDEOS AND PICTURES FROM THREE MONTHS AFTER, ALTHOUGH I WAS UNABLE TO TAKE PHOTOS FOR WEEKS DUE TO THE EMOTIONAL IMPACT. NOW, FIVE MONTHS LATER, I HAVE EXPERIENCED ONLY SLIGHT IMPROVEMENT. THE CLINIC DENIES RESPONSIBILITY AND REFUSES TO OFFER A SOLUTION. I FEEL UNPROTECTED AND SERIOUSLY AFFECTED IN TERMS OF SKIN HEALTH. I AM REQUESTING CLEAR GUIDANCE AND INFORMATION ON WHETHER THIS TYPE OF COMBINED AND PROLONGED APPLICATION OF PRX-T33 AND MICRONEEDLING IS CONSIDERED SAFE OR APPROPRIATE. REFERENCE REPORT#: MW5170348.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 5/21/2025 FOR MW5170347 TO UPDATE MANUFACTURER. REF REPORT: MW5170348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749218 PRX-T33 (MICRONEEDLING DEVICE) MICRONEEDLING DEVICE FOR AESTHETIC USE QAI DERMA PEN, LLC. 0018524

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Disability| O| R BIOLOGIQUE RECHERCHE FACE CREAM.| DERMALOGICA EYE CREAM.| DERMALOGICA NECK CREAM. | EUCERIN MOISTURIZER.| GENTLE NIVEA CLEANSER,.| HIGH-SILICA WATER.| HYALURONIC ACID SERUM.| LISTIC SUPPLEMENT.