BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE DEFYNE

    MDR report key: 15908609 · Received December 2, 2022

    Report

    Report Number
    9710154-2022-00073
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 1, 2022
    Report Date
    December 2, 2022
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P140029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENT OF VASCULAR OCCLUSION AND THE NON-SERIOUS EVENTS OF PAIN, PALLOR AT IMPLANT SITE AND SCAB AT INJECTION SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION AND THEIR MANIFESTATIONS. POTENTIAL CONTRIBUTORY FACTOR INCLUDES INJECTION TECHNIQUE. THE RESTYLANE DEFYNE WAS USED OFF LABEL. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. PRODUCT NOTE: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE. LOT NUMBER WAS NOT REPORTED AND THE PRODUCT COULD NOT BE VERIFIED. 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. RECOMMENDATION FOR CORRECTIVE AND PREVENTATIVE ACTION: 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) 2022 BY AN OTHER HEALTH PROFESSIONAL WHICH REFERS TO A 35-YEAR-OLD FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 FROM THE SAME REPORTER. THE PATIENT HAD NO KNOWN MEDICAL HISTORY OR ALLERGIES. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH VERSEA AND RESTYLANE KYSSE FOR FIVE TO SIX TIMES FOR COSMETIC INDICATION. ON AN UNKNOWN DATE, THE PATIENT HAD RECEIVED UNSPECIFIED COVID-19 VACCINE INCLUDING THREE BOOSTER DOSES. IN THE BEGINNING OF (B)(6) 2022, THE PATIENT HAD RECEIVED FLU VACCINE. ON (B)(6) 2022, THE PATIENT RECEIVED TREATMENT WITH ABOUT 1 ML OF RESTYLANE DEFYNE TO LIPS (UNKNOWN LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). THE RESTYLANE DEFYNE WAS INJECTED TO LIPS (OFF LABEL USE OF DEVICE). ON (B)(6) 2022, THE PATIENT STARTED EXPERIENCING IRREGULAR PAIN (IMPLANT SITE PAIN) THAT WAS TRAVELLING UP TO THE TIP OF HER NOSE AND BLANCHING (IMPLANT SITE PALLOR). THE HCP DIAGNOSED THE CONDITION AS VASCULAR OCCLUSION (VASCULAR OCCLUSION) AND TREATED THE PATIENT WITH 2 ML OF HYLENEX [VORHYALURONIDASE ALFA] ON (B)(6) 2022. SHE WAS STILL HAVING SOME PAIN, THEN HCP TREATED THE PATIENT WITH ANOTHER 4 ML OF HYLENEX ON (B)(6) 2022. AS OF (B)(6) 2022, THE PATIENT HAD SOME ALTERATION TO THE AREA WITH SCAB FORMATION (INJECTION SITE SCAB). HER PAIN HAD DECREASED SIGNIFICANTLY. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERING/RESOLVING. IRREGULAR PAIN WAS RECOVERING/RESOLVING. BLANCHING WAS RECOVERING/RESOLVING. SCAB FORMATION WAS NOT RECOVERED/NOT RESOLVED/ONGOING. RESTYLANE DEFYNE WAS INJECTED TO LIPS WAS RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403106 RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention