BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 18311777 · Received December 12, 2023

    Report

    Report Number
    9710154-2023-00086
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    November 18, 2023
    Report Date
    December 12, 2023
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024 S140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENT OF NECROSIS AT IMPLANT SITE AND THE NON-SERIOUS EVENTS OF PAIN, OEDEMA, ERYTHEMA AND HYPERSENSITIVITY AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE INCLUDES INJECTION PROCEDURE LEADING TO VASCULAR COMPROMISE WITH NECROTIC MANIFESTATIONS. POTENTIAL CONTRIBUTORY FACTOR FOR IMPLANT SITE NECROSIS INCLUDES INJECTION TECHNIQUE. THE CASE MEETS THE 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 NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. 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 21-NOV-2023 BY AN OTHER HEALTH PROFESSIONAL, WHICH REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE. ADDITIONAL INFORMATION WAS RECEIVED ON 21-NOV-2023 AND 22-NOV-2023 FROM THE SAME REPORTER. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, OR HISTORY OF ALLERGIES HAS BEEN PROVIDED. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH PMMA (THIS INFORMATION WAS NOT SHARED BY THE PATIENT DURING THE FIRST CONSULTATION WITH THE REPORTER). ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 1 ML OF RESTYLANE (LOT: 21041-1), 0.5 ML TO EACH SIDE OF NASOLABIAL AREA USING CANNULA WITH UNKNOWN INJECTION TECHNIQUE. ON (B)(6) 2023, THE PATIENT EXPERIENCED EDEMA (IMPLANT SITE OEDEMA), PAIN (IMPLANT SITE PAIN), AND REDNESS (IMPLANT SITE ERYTHEMA). THE PATIENT ALSO EXPERIENCED HYPERSENSITIVITY (IMPLANT SITE HYPERSENSITIVITY). ON (B)(6) 2023, THE PATIENT'S SYMPTOMS WORSENED AND BASED ON THE SKIN LESION, SHE WAS DIAGNOSED WITH THE BEGINNING OF A NECROTIC PROCESS (IMPLANT SITE NECROSIS), ACCORDING TO THE PROFESSIONAL. ON AN UNKNOWN DATE ON (B)(6) 2023, THE PATIENT WENT TO THE EMERGENCY ROOM WHERE SHE UNDERWENT AN ULTRASOUND AND THE RESULTS SHOWED PRESERVATION OF THE VESSELS AND BLOOD FLOW AND SHE RECEIVED TREATMENT WITH AN UNSPECIFIED ANALGESIC. THE REPORTING HCP DECIDED TO REFER THE PATIENT TO A PLASTIC SURGEON FOR EVALUATION. ON AN UNKNOWN DATE ON (B)(6) 2023, THE PLASTIC SURGEON PERFORMED HYALURONIDASE [HYALURONIDASE] TREATMENT. THE REPORTING HCP WAS UNABLE TO SPECIFY THE QUANTITY, BUT BELIEVED THAT IT WAS 2000 UTR IN TOTAL, AND WAS MONITORING THE PATIENT. OUTCOME AT THE TIME OF THE REPORT: NECROTIC PROCESS WAS NOT RECOVERED/NOT RESOLVED/ONGOING. EDEMA WAS UNKNOWN. PAIN WAS UNKNOWN. REDNESS WAS UNKNOWN. HYPERSENSITIVITY WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579927 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED 21041-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention