BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAFORM

    MDR report key: 687496 · Received March 14, 2006

    Report

    Report Number
    2246315-2006-00017
    Event Type
    Injury
    Date Received
    March 14, 2006
    Report Date
    February 14, 2006
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FACIAL SWELLING, REDNESS (FACE). A LITERATURE ARTICLE WAS RECEIVED ON 14-FEB-2006 TITLED: "RANDOMIZED, DOUBLE-BLIND COMPARISON OF THE EFFICACY OF TWO HYALURONIC ACID DERIVATIVES, RESTYLANE PERLANE ADN HYLAFORM, IN THE TREATMENT OF NASOLABIAL FOLDS (ALASTAIR CARRUTHERS, M.D. DERMATOL SURG 2005; 31; 1591-1598). A PATIENT (UNKNOWN DEMOGRAPHICS) EXPERIENCED A SUSPECTED ALLERGIC REACTION CHARACTERIZED BY SEVERE FACIAL SWELLING AND REDNESS 10 DAYS AFTER TREATMENT WITH HYLAFORM. THE PATIENT WAS TREATED WITH AN UNSPECIFIED CORTICOSTEROID AND ANTIBIOTIC. THE EVENTS RESOLVED WITHIN 3 WEEKS. QA INVESTIGATION RESULTS: REVIEW OF THE DATA DID NOT INDICATE TRENDS THAT COULD BE ASSOCIATED TO ANY PRODUCT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAFORM DERMAL IMPLANT FOR AESTHETIC USE LMH GENZYME BIOSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention