BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 4666928 · Received March 24, 2015

    Report

    Report Number
    1000118068-2015-00001
    Event Type
    Injury
    Date Received
    March 24, 2015
    Report Date
    February 24, 2015
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: GALDERMA LABORATORIES L.P. (B)(4). PHARMACOVIGILANCE COMMENT: A CAUSAL RELATION BETWEEN THE EVENT AND THE TREATMENT CANNOT BE EXCLUDED. THE VASCULARISATION OF THE NOSE TIP MAY BE ALTERED BY A SURGICAL PROCEDURE. ISOLATED RARE CASES OF ISCHEMIA/NECROSIS AFFECTING THE NOSE FOLLOWING INJECTION TREATMENT IN PTS WHO HAD PRIOR RHINOPLASTY, HAVE BEEN REPORTED. THE REPORTED EVENT IS ADDRESSED IN THE LABEL. THIS LITERATURE ARTICLE DESCRIBES THAT THE PT WAS INJECTED WITH A HYALURONIC ACID FILLER. ALTHOUGH THE PRODUCT NAME IS NOT REPORTED, IT CANNOT BE EXCLUDED THAT A Q-MED PRODUCT IS INVOLVED.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED (B)(6). AFTER FOUR RHINOPLASTIES, THIS (B)(6) WOMAN WAS INJECTED WITH A HYALURONIC ACID FILLER TO IMPROVE TIP PROJECTION. "THE TIP TURNED WHITE AND THEN BLACK" WITH NECROSIS. THE WOUND HEALED SECONDARILY. THE SKIN OF THE TIP AND DORSUM WAS SCARRED. THE TIP LACKED PROJECTION. HER BREATHING WAS SATISFACTORY. THIS PAPER ILLUSTRATED THE USE OF A 3 STAGE FOREHEAD FLAP AND ANATOMIC RECONSTRUCTION OF THE TIP CARTILAGES TO REPAIR A FULL THICKNESS NECROSIS OF THE TIP AFTER A COSMETIC FILLER INJECTION. AN OVERVIEW OF PRESENTATION AND TREATMENT OF THIS COMPLICATION IS PRESENTED WITH RECONSTRUCTIVE GUIDELINES TO DIRECT THE SURGEON TO SUCCESSFUL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197617 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE (LMH) LMH GALDERMA Q-MED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention