BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HA DERMAL FILLER

    MDR report key: 3971007 · Received July 8, 2014

    Report

    Report Number
    2024601-2014-00354
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    November 15, 2011
    Report Date
    June 12, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT OF A ISCHEMIA WITH NECROTIC CRUST, PAIN, "DUSKY BLUE-PINKISH ERYTHEMA" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IN THE ARTICLE "RETICULATED ERYTHEMA AFTER NASOLABIAL FOLD INJECTION WITH HYALRUONIC ACID: THE IMPORTANCE OF IMMEDIATE ATTENTION", AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY NOV 2011; 37: 1697-1699, THE AUTHORS DESCRIBE A CASE STUDY INVOLVING A PATIENT WHO EXPERIENCED AN ADVERSE EVENT AFTER BEING INJECTED WITH A CROSS-LINKED HYALURONIC ACID BASED FILLER. SPECIFICALLY: 1 HOUR AFTER INJECTION WITH HYALURONIC ACID DERMAL FILLER (20MG/ML CONCENTRATION, TOTAL VOLUME OF 2 ML) IN THE NASOLABIAL FOLDS THE PATIENT DEVELOPED "DUSKY BLUE-PINKISH ERYTHEMA" WITH "RETICULAR DISTRIBUTION" ON THE CENTRAL FACE. "IT WAS SUSPECTED THAT THE BRANCHES OF THE ARTERY (FACIAL ARTERY OR ANGULAR ARTERY) WERE COMPRESSED, LEADING TO ISCHEMIA AND POSSIBLE SKIN NECROSIS". THE DAY FOLLOWING INJECTION THE PATIENT WAS TREATED WITH "20 U HYALURONIDASE ONCE AND WARM SALINE COMPRESS TWICE A DAY TO THE NOSE OVER AN OBVIOUS RETICULATED AREA. WITHIN 48 HOURS, THE PATIENT DEVELOPED AN APPROXIMATELY 0.5 -CM NECROTIC CRUST ON THE LEFT NASAL TIP WITH PAIN AND TENDERNESS ON THE ENTIRE NOSE. THIS CRUSTED AREA WAS CONSERVATIVELY MANAGED WITH BACITRACIN OINTMENT". WITHIN 3 WEEKS THE PATIENT MADE A "FULL RECOVERY". ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397874 UNK HA DERMAL FILLER LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention