BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT

    MDR report key: 22868100 · Received August 21, 2025

    Report

    Report Number
    1000118068-2025-00018
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 21, 2025
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENTS OF HYPERSENSITIVITY, OEDEMA AT IMPLANT SITE AND THE NON-SERIOUS EVENTS OF NODULE AND PAIN AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDES NEED FOR MULTIPLE MEDICAL AND SURGICAL INTERVENTIONS AND HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE OR THE PATIENT'S HYPERSENSITIVITY TO THE PRODUCT. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE OR THE PRODUCT. THE REPORTED LOT NUMBERS WERE VALID AND VERIFIED THE REPORTED PRODUCTS. TO DATE, NO ADDITIONAL MEDICAL COMPLAINT WAS REPORTED FOR RESTYLANE CONTOUR WITH THE LOT NUMBER 22764. A BATCH RECORD REVIEW WAS PERFORMED FOR THE LOT NUMBER AND REVEALED NO POTENTIAL QUALITY ISSUES DURING THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. 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. 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 (B)(6) 2025 BY A PHYSICIAN ASSISTANT CONCERNING A 63-YEAR-OLD FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JUL-2025, 31-JUL-2025 AND 08-AUG-2025 FROM THE SAME REPORTER. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR HISTORY OF ALLERGIES HAS BEEN PROVIDED. THE PATIENT HAD PREVIOUSLY RECEIVED A TREATMENT WITH AN UNSPECIFIED FILLER IN 2018 AT ANOTHER FACILITY. ON (B)(6) 2025, THE PATIENT RECEIVED A TREATMENT WITH RESTYLANE CONTOUR (LOT 22764) TO THE MEDIAL CHEEK AND RESTYLANE LYFT WITH LIDOCAINE (LOT 22126) TO THE LATERAL CHEEK (UNKNOWN AMOUNT, INJECTION TECHNIQUE AND NEEDLE TYPE) FOR CHEEK AUGMENTATION. ON THE SAME DAY, THE PATIENT ALSO RECEIVED A TREATMENT WITH RESTYLANE KYSSE (LOT 22527) TO THE LIPS (UNKNOWN AMOUNT, INJECTION TECHNIQUE AND NEEDLE TYPE) FOR LIP AUGMENTATION. ON (B)(6) 2025, THE PATIENT PRESENTED TO HCP REPORTING THAT HER CHEEKS WERE TENDERNESS/SORE/PAIN (IMPLANT SITE PAIN) WITH SOME SMALL FIRMNESS/HARD NODULES (IMPLANT SITE NODULE). THE EXAMINATION REVEALED MILD TENDERNESS TO BILATERAL CHEEKS. SUBSEQUENTLY, THE HCP INITIATED A TREATMENT WITH PREDNISONE [PREDNISONE] 20MG BID FOR 5 DAYS AND AUGMENTIN [AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM] 875/125MG BID FOR 10 DAYS. ON (B)(6) -2025, THE PATIENT HAD A FOLLOW-UP APPOINTMENT AFTER ANTIBIOTICS AND STEROIDS ADMINISTRATION AND THERE WAS COMPLETE IMPROVEMENT OBSERVED. ON (B)(6) 2025, TWO WEEKS LATER, THE PATIENT PRESENTED TO HCP WITH SEVERE SWOLLEN/EDEMA (IMPLANT SITE OEDEMA) CHEEKS, AND TENDERNESS/PAIN TO THE CHEEKS. SHE EXPERIENCED A DELAYED HYPERSENSITIVITY REACTION (IMPLANT SITE HYPERSENSITIVITY). THERE WAS NO SWELLING, OR TENDERNESS OBSERVED IN THE LIPS AT THAT TIME. AS THERAPEUTIC MEASURE TAKEN, THE HCP INJECTED THE PATIENT WITH A TOTAL 4 VIALS OF HYLENEX [VORHYALURONIDASE ALFA], 2 VIALS PER CHEEK. LATER, THE PATIENT WAS SUBSEQUENTLY SENT TO THE HOSPITAL. ON (B)(6) 2025, THE SAME DAY, THE PATIENT WAS ADMITTED TO HOSPITAL AND UNDERWENT A NEEDLE ASPIRATION TO LEFT CHEEK WHICH SHOWED A MILKY WHITE FLUID THAT WAS SENT FOR CULTURE, AND THERE WAS NO GROWTH OBSERVED AT 24 HOURS. ON (B)(6) 2025, THE PATIENT UNDERWENT A CT SCAN OF THE FACE WITH CONTRAST AGENT AND BASED ON THE RESULTS, THE HCP MADE FOLLOWING ASSESSMENT: 1. THERE WAS EVIDENCE OF SUBTLE THICKENING AND SUBCUTANEOUS STRANDY SOFT TISSUE EDEMA ABOUT THE BILATERAL FACIAL SOFT TISSUES EXTENDING TO THE REGION OF THE BILATERAL ORBITS. 2. THERE WERE SUBTLY RIM ENHANCING MULTILOCULAR/MULTILOBULATED FLUID COLLECTIONS IN THE BILATERAL PREMAXILLARY FACIAL SOFT TISSUES WITH SMALL INTRALOCULE SUB GAS AND SUBTLE SUBCUTANEOUS SOFT TISSUE EMPHYSEMA ALONG THE ANTERIOR ASPECT LEFT COLLECTION. THESE COLLECTIONS COULD REFLECT POSTOPERATIVE COLLECTION SUCH AS HEMATOMAS OR SEROMAS, HOWEVER, INFECTED COLLECTION/ABSCESS SHOULD BE CONSIDERED. 3. THE LEFT FACIAL SUBCUTANEOUS SOFT TISSUE COLLECTION APPEARED TO HAVE A LOBULATED COMPONENT DISSECTING INTO THE ANTERIOR MARGIN OF THE LEFT MASSETER MUSCLE. THE LEFT MASSETER MUSCLE APPEARED THICKENED AND SLIGHTLY INDISTINCT WHICH COULD REFLECT NONSPECIFIC MYOSITIS. ON THE SAME DAY, THE PATIENT ALSO UNDERWENT FOLLOWING LABORATORY TESTS AND RESULTS SHOWED AS FOLLOWS: WBC 12.3, GRANULOCYTES 75%, LYMPHOCYTES 15%, BASOPHILS 0.9%, CRP 14.42, PROCALCITONIN < 0.05, ANA PANEL WAS NEGATIVE. THE GRAM STAIN WAS NEGATIVE BUT LARGE NUMBERS OF WBCS WERE OBSERVED. ON (B)(6) 2025, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR MAXILLOFACIAL SURGERY AND SHE UNDERWENT THE SURGERY ON (B)(6) 2025. THE REPORTER STATED THAT SHE HAD SMALL INCISION ON EACH CHEEK, TWO TUBE DRAINS WERE PLACED IN THE MOUTH, AND THE CULTURE RESULTS WERE NEGATIVE. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SWELLING AND PAIN WAS COMPLETELY RESOLVED. OUTCOME AT THE TIME OF THE REPORT: TENDERNESS/SORE/PAIN WAS RECOVERED/RESOLVED. FIRMNESS/HARD NODULES WAS RECOVERED/RESOLVED. DELAYED HYPERSENSITIVITY REACTION WAS RECOVERED/RESOLVED. SWOLLEN/EDEMA WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL. BATCH RECORD REVIEW RESULTS RECEIVED ON 19-AUG-2025 FOR LOT NUMBERS 22764 (RESTYLANE CONTOUR) AND 22126 (RESTYLANE LYFT LIDOCAINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408189 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB 22126

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H