BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 185633 · Received September 3, 1998

    Report

    Report Number
    2939859-1998-00214
    Event Type
    Injury
    Date Received
    September 3, 1998
    Date of Event
    June 12, 1998
    Report Date
    August 6, 1998
    Manufacturer
    COLLAGEN CORP
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO WAS SKIN TESTED ON 1/13/1998 AND WAS TREATED ON 3/13/1998 INTO THE NASOLABIAL, GLABELLA AND CHIN. ON 6/12/1998, THE PT DEVELOPED ERYTHEMATOUS THICKENING IN THE GLABELLA AND NASOLABIAL LINES. THE PHYSICIAN PRESCRIBED NOVASANE. ON 6/26/1998, THE AREAS WERE LUMPY, ERYTHEMATOUS AND THICKENED IN THE GLABELLA NASOLABIAL LINES. ON 6/26/1998 AND 7/17/1998, THE PHYSICIAN PRESCRIBED INTRALESIONAL KENACORT A10. ON 7/17/1998, THE AREAS WERE SETTLING. ON 8/6/1998, THE TEST SITE WAS REACTIVE, AND THE NASOLABIAL AND GLABELLA WERE STILL VERY RED AND THICKENED. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IRON