BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 8420196 · Received March 14, 2019

    Report

    Report Number
    9710154-2019-00005
    Event Type
    Injury
    Date Received
    March 14, 2019
    Report Date
    March 13, 2019
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE SUSPECT PRODUCT WAS NOT SPECIFIED. LOT NUMBER WAS NOT PROVIDED. CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENTS OF IMPLANT SITE SCAR AND VASCULAR OCCLUSION, AND THE NON-SERIOUS EVENTS OF DISCOLOURATION, PAIN AND BRUISING AT THE IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED PERMANENT DAMAGE. THE SUSPECT PRODUCT WAS REPORTED AS AN UNSPECIFIED HYALURONIC ACID FILLER; HOWEVER, WE CANNOT EXCLUDE THAT ONE OF OUR HYALURONIC ACID FILLER PRODUCTS HAS BEEN USED. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EXEMPTION: GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005 - ATTACHMENT: [GL19-004479LITERATURE.PDF]

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER US19008813 IS A LITERATURE REPORT RECEIVED ON 20-FEB-2019. FITZGERALD ET AL., ADVERSE REACTIONS TO INJECTABLE FILLERS. FACIAL PLAST SURG 2016;32:532-555. THIS PATIENT WAS TREATED WITH AN UNSPECIFIED HA FILLER IN THE PREAURICULAR AREA, WHICH WAS INADVERTENTLY INJECTED INTO HER SUPERFICIAL TEMPORAL ARTERY. THIS WAS NOT NOTED AT THE TIME OF INJECTION. THE PATIENT LATER CALLED HER PRACTITIONER WITH COMPLAINTS OF PAIN AND DISCOLORATION BUT WAS TOLD OVER THE PHONE THAT IT WAS LIKELY BRUISING. NO TREATMENT WAS UNDERTAKEN FOR OVER A WEEK AND SHE WAS LEFT WITH SIGNIFICANT RESIDUAL SCARRING IN THE DISTRIBUTION OF THE VESSEL AT TEMPLE AND SCALP (AS SEEN ON PHOTOS). THE PATIENT WAS SHOWN MONTHS OUT FROM AN OCCLUSIVE EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212511 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability