BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 280442 · Received May 31, 2000

    Report

    Report Number
    2939859-2000-00076
    Event Type
    Injury
    Date Received
    May 31, 2000
    Date of Event
    May 15, 2000
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 2939859-2000-00067 (MCGHAN MEDICAL CORP #1026777). THIS SECOND MDR IS BEING SUBMIITED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVCIE MANUFACTURED BY MCGHAN MEDICAL CORP. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. A PT WAS SKIN TESTED IN THE RIGHT FOREARM WITH 16 MARCH 2000 WITH NEGATIVE RESULTS. THE PT WAS TREATED IN THE NASOLABIAL FOLDS WITH ONE FORMULATION OF COLLAGEN LAYERED WITH A SECOND FORMULATION OF COLLAGEN. IT WAS THE INITIAL USE FOR BOTH SYRINGES AND THE "ADG" NEEDLE IN BOTH CASES. THE TREATMENT WAS UNEVENTFUL AND BOTH PT AND INJECTOR WERE PLEASED WITH THE RESULTS. THREE WEEKS AFTER THE TREATMENT THE PT BEGAN TO HAVE SWELLING AND ITCHKING BILATERALLY AT THE TREATMENT SITES. PT WAS SEEN IN THE OFFICE 15 MAY 2000 AND THE "PUFFINESS" WAS PALPABLE AT THE LOWER END OF THE NASOLABIAL FOLDS NEAR THE ORAL COMMISURES. THE PT DENIES ERYTHEMA, INDURATION, OR BRUISING. THE PHYSICIAN PRESCRIBED TOPICORT, TOPICAL LOTION AND ORAL REACTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT LMH MCGHAN MEDICAL CORP. NA 99K101A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention