BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT

    MDR report key: 283777 · Received June 27, 2000

    Report

    Report Number
    2939859-2000-00089
    Event Type
    Injury
    Date Received
    June 27, 2000
    Date of Event
    March 1, 1999
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 2939859-1999-00090. THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MANUFACTURED BY COLLAGEN CORP. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. A REPORT WAS FAXED FROM, SOUTH KOREA TO MCGHAN MEDICAL CORP. THE FAX CONTAINS A REPORT OF TWO EVENTS FOR THE SAME PT. THE PT WAS INJECTED IN THE FOREHEAD IN 1998 WITH TWO FORMULATIONS OF COLLAGEN LAYERED. THE REPORT DESCRIBES A CRUST THAT APPEARED AT THE INJECTION SITE 4 DAYS POST TREATMENT THAT WAS "HEALED BY THE DOCTOR'S THERAPY" ONE YEAR LATER THE SITE DEVELOPED A 2 CM PRURITIC MACULA THAT WAS A "YELLOW-PINK" COLOR. AN UNSPECIFIED ORAL DRUG WAS ADMINISTERED THAT GAVE SOME RELIEF. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT LMH MCGHAN MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention