BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT (VOLUME UNSPECIFIED)

    MDR report key: 1716617 · Received June 9, 2010

    Report

    Report Number
    2024601-2010-00439
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF: "LOCAL ALLERGIC REACTION CHARACTERIZED BY FACIAL SWELLING, REDNESS, AND ITCHINESS APPROXIMATELY 48 HOURS POSTINJECTION" FROM JOURNAL ARTICLE, "CASE STUDY OF DERMICOL-P35 USED IN PATIENT WITH PAST HYPERSENSITIVITY TO CROSSLINKED BOVINE COLLAGEN DERMAL FILLER", AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY, INC., DERMATOL SURG; 2010; 36:825-827, WILEY PERIODICALS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT (VOLUME UNSPECIFIED) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention