BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 6622332 · Received June 8, 2017

    Report

    Report Number
    9710154-2017-00039
    Event Type
    Injury
    Date Received
    June 8, 2017
    Report Date
    May 24, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING EXEMPTION NUMBER (B)(4). (B)(4) IS SUBMITTING ON BEHALF OF Q-MED (B)(4) (MANUFACTURER) . (B)(4). CAPA: THE EVENTS ARE EXPECTED. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENT OF IMPLANT SITE NECROSIS INCLUDING THE NON-SERIOUS SYMPTOMS OF DISCOLORATION, PAIN AND PUSTULES WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED THE NEED FOR MEDICAL CARE, AND TREATMENT WITH HYALURONIDASE, NITROGLYCERIN AND EASYEF. THE PATIENT RECOVERED COMPLETELY WITHIN FOUR WEEKS. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: DEVICE NOT AVAILABLE FOR TESTING.

    Description of Event or Problem · 1

    (B)(4) IS A LITERATURE REPORT RECEIVED ON 24-MAY-2017. HONG JY ET AL. SKIN NECROSIS AFTER FILLER-ASSOCIATED VASCULAR COMPROMISE: SUCCESSFUL TREATMENT WITH TOPICAL EPIDERMAL GROWTH FACTOR. INT WOUND J. 2017 JUNE; 14(3): 587-588. A (B)(6) FEMALE PRESENTED WITH A DIFFUSE DUSKY RED PAINFUL PATCH ON THE RIGHT NASOLABIAL FOLD, CHEEK AND NASAL DORSUM. SHE HAD RECEIVED A RESTYLANE INJECTION IN BOTH NASOLABIAL FOLDS THE DAY BEFORE PRESENTATION. HYALURONIDASE WAS INJECTED IMMEDIATELY INTO THE LESIONAL SITE TO RESOLVE AND DISPERSE THE HA FILLER MATERIALS. SUBLINGUAL NITROGLYCERIN AND LOW-DOSE ASPIRIN WERE ALSO PRESCRIBED TO INCREASE LESIONAL BLOOD FLOW AND TO PREVENT FURTHER CLOT FORMATION, RESPECTIVELY. A WET DRESSING WAS APPLIED TWICE DAILY UNTIL NO NEWLY DEVELOPED PUSTULES WERE OBSERVED AT DAY 5. TOPICAL RECOMBINANT HUMAN EPITHELIAL GROWTH FACTOR SOLUTION (EASYEF 0.005%, DAEWOONG PHARMACEUTICAL CO., LTD., SEOUL, KOREA) WAS APPLIED TO THE OCCLUSIVE WET DRESSING APPLIED TO THE NECROTIC ULCER ONCE DAILY FOR 2 WEEKS. THE WOUND SHOWED GRADUAL REEPITHELISATION AND WAS COMPLETELY RESOLVED AFTER 4 WEEKS, LEAVING NO RESIDUAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403934 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention