BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT

    MDR report key: 24794227 · Received April 6, 2026

    Report

    Report Number
    9710154-2026-00021
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 6, 2026
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENT OF VASCULAR OCCLUSION WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE INCLUDES THE INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND HAVE PROVIDED SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO DATE, THIS IS THE ONLY CASE REPORT RECEIVED FOR THIS LOT NUMBER. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED UNLESS FURTHER INFORMATION IS RECEIVED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 09-MAR-2026 BY A PHYSICIAN CONCERNING A 46-YEAR-OLD FEMALE PATIENT. THE PATIENT HAD NO KNOWN ALLERGIES AND WAS NOT PREGNANT. NO INFORMATION ABOUT MEDICAL HISTORY HAS BEEN PROVIDED. SHE WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH RESTYLANE LYFT TO CHIN IN (B)(6) 2025. ON (B)(6) 2026, THE PATIENT RECEIVED TREATMENT WITH 1 ML OF RESTYLANE LYFT LIDOCAINE (LOT 24026-2), 0.3 ML TO CENTER OF CHIN ON BONE USING NEEDLE AND 0.7 ML TO CHIN FOR SHAPE USING CANNULA WITH UNKNOWN INJECTION TECHNIQUE. ON (B)(6) 2026, THE PATIENT EXPERIENCED MODERATE VASCULAR OCCLUSION (VASCULAR OCCLUSION) ON THE LEFT SIDE OF CHIN. THE PATIENT RECEIVED CORRECTIVE TREATMENT WITH HYALASE [HYALURONIDASE] 1.5 AMPOULES AND 2 TABLETS OF ECOTRIN [ACETYLSALICYLIC ACID] ON 06-MAR-2026. SHE ALSO RECEIVED FOUR-TIME TREATMENTS WITH HYPERBARIC CHAMBER AND THE TREATMENT WAS ONGOING. POST TREATMENT, THERE WAS REVASCULARIZATION AND THE EVENT WAS RESOLVING. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856099 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB 24026-2

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention