BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW-FILL

    MDR report key: 9734418 · Received February 20, 2020

    Report

    Report Number
    9710154-2020-00034
    Event Type
    Injury
    Date Received
    February 20, 2020
    Report Date
    February 20, 2020
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P030050/S2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EXPECTED EVENT OF NODULE AT IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED THE NEED FOR SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. POTENTIAL CONTRIBUTORY FACTOR INCLUDE INJECTION TECHNIQUE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. 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. (B)(4).

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT DETECTED ON 03-JUN-2017 BY MEDICAL AFFAIRS DEPARTMENT DURING A LITERATURE SCREENING. THIS CASE WAS IDENTIFIED IN THE ARTICLE MOLE B. LONG-LASTING FILLING PROCEDURES. ANN DERMATOL VENEREOL. 2008;135:1S39-47. DOI: 10.1016/S0151-9638(08)70210-2. A PATIENT OF UNKNOWN AGE AND GENDER RECEIVED TREATMENT WITH NEW-FILL IN THE ORBITAL REGION. UNKNOWN TIME LATER TREATMENT, THE PATIENT DEVELOPED SUPERFICIAL NODULES THAT READILY CALCIFIED AT TREATED AREA. CORRECTIVE TREATMENT INCLUDED DIRECT EXCISION OF THE NODULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197434 NEW-FILL IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention