BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 287944 · Received August 1, 2000

    Report

    Report Number
    2939859-2000-00117
    Event Type
    Injury
    Date Received
    August 1, 2000
    Date of Event
    April 25, 2000
    Manufacturer
    MCGHAN MEDICAL CORPORATION
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS SKIN TESTED IN 1993, AND RE-TESTED APPROX ONE MONTH LATER IN 1993. THE RESULTS OF BOTH TESTS WERE NEGATIVE. PT REC'D COLLAGEN TREATMENTS FOR A NUMBER OF YEARS, THEN WENT SEVERAL YEARS WITHOUT RECEIVING COLLAGEN. IN 2000, PT REC'D 1 CC OF COLLAGEN IN THE FOREHEAD, CROWSFEET, ORAL COMMISSURES, AND UPPER VERMILION BORDER. AROUND THE END OF THE FOURTH MONTH IN 2000, PT NOTICED ONSET OF LUMPINESS ON PT'S FOREHEAD. PHYSICIAN SAW PT IN THE FIFTH MONTH OF 2000 AND CONFIRMED PRESENCE OF LUMPS. IN THE 6TH MONTH OF 2000, PHYSICIAN SAW PT WHO REPORTED ITCHING AND RASH ON ARMS, CHEST, AND FOREHEAD APPROX IN THE MIDDLE OF THE 6TH MONTH OF 2000. PHYSICIAN HAS DIAGNOSED HYPERSENSITIVITY AND ALLERGIC URTICARIA (LICHENOID DERMATITIS) DIRECTLY RELATED TO THE COLLAGEN. PHYSICIAN HAS TREATED SYMPTOMS AS FOLLOWS: IN 2000 - TRIAMCINILONE DIACETATE-INTRALESIONAL - FOREHEAD. 06/22/2000 - ZYRTEC 10 MG - BY MOUTH, 06/22/2000 - CLARITIN 10MG - BY MOUTH, 06/22/2000 - DERMATOR CREAM - TOPICALLY, 06/28/2000 - MEDROL DOSE PACK - BY MOUTH, 06/28/2000 - ATARAX - BY MOUTH, 06/30/2000 - PREDNISONE 60MG - BY MOUTH, 06/30/2000 - CELESTONE - 1CC INTRAMASCULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT LMH MCGHAN MEDICAL CORPORATION NA 99D041D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention DERMOLOGEN.