BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 24954834 · Received April 22, 2026

    Report

    Report Number
    MW5187150
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 17, 2026
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM REPORTING A DELAYED INFLAMMATORY REACTION TO THE ADMINISTRATION OF SCULPTRA AND RESTYLANE DONE ON (B)(6) 2026 AT THE OFFICE OF DR. (B)(6). PRE-EXISTING BASELINE: I HAVE ZERO HISTORY OF ROSACEA, PERIORAL DERMATITIS OR ENVIRONMENTAL SKIN ALLERGIES. AREAS TREATED TO MY KNOWLEDGE: TEMPLES, CHEEKS, JAW, AROUND THE MOUTH, NECK AND NASOLABIAL FOLDS. 1 DAY ONSET: STARTED WITH SEVERE PAIN IN BOTH OF THE EARS, WAS TOLD IT WAS INFLAMMATION RELATED AND IT WAS SUGGESTED I HAD TWO EARS INFECTIONS 3 WEEK ONSET: I SEEMED TO BE FINE, EVEN WENT TO MY FOLLOW UP VISIT, THEN SUDDENLY A REACTION STARTED TO FLARE. REGIONAL SPREAD: IT SEEMED TO START AROUND INJECTION SITES ON JAW, THEN SPREAD TO CHIN, NOSE AND SURROUNDING TISSUE. PROVIDER CLAIMS A PRODUCT LINK WAS IMPOSSIBLE BECAUSE IT SPREAD TO U TOUCHED AREAS AND SUGGESTED PERHAPS IT WAS A RASH OR A SINUS INFECTION AND DUAL EAR INFECTIONS- ALL RULED OUT. THE INJECTOR IGNORED MY SUGGESTION OF DOCUMENTED REGIONAL INFLAMMATORY SPREAD. TREATMENT FAILURE: TACROLIMUS, DOXYCYCLINE, METRO GEL, CLINDAMYCIN, HYDROCORTISONE AND PREDNISONE ALL FAILED FOR THE MOST PART, WITH LITTLE TO NO CLINICAL IMPROVEMENT. RASH PRESENTATION: CONFLUENT ERYTHEMATOUS PAPULES, EDEMA AND PUSTULES. CONFLICT: OFFICE APPEARS TO BE WITHHOLDING LOT NUMBERS USED AND ASKING ONLY FOR MEDICAL RECORDS AND ADDITIONAL PHOTOS. I HAVE NOT HEARD FROM THE OFFICE MANAGER, NOR DR. (B)(6), ONLY THE PA VIA TEXT MESSAGE. PATIENT: 1930, 4812, 2033, 4542, 4577, 2035. DEVICE: 2682, 3023. REF MW5187149.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168476 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Disability| R| O DOXYCYCLINE| GABAPENTIN| METRO GEL| MULTI VITAMIN| NAPROXEN| PROBIOTIC| VALIUM