BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 249800 · Received November 12, 1999

    Report

    Report Number
    2939859-1999-00232
    Event Type
    Injury
    Date Received
    November 12, 1999
    Date of Event
    April 1, 1999
    Report Date
    August 30, 1999
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 2939859-1999-00231 (COLLAGEN CORP). THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MFG BY COLLAGEN CORP. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. A PHYSICIAN REPORTED A PT WHO WAS ORIGINALLY SKIN TESTED ON 2/9/99 WITH NEGATIVE RESULTS. ON 3/17/99 THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT AT THE CHIN, NASOLABIAL FOLDS, AND VERMILION BORDERS. ON 5/6/99 THE PT CALLED THE OFFICE AND STATED SHE HAD RED, RAISED "BUMPS" WITH ITCHING AT THE NASOLABIAL FOLDS AND CHIN TREATMENT SITES. THE PT STATED THE SYMPTOMS BEGAN ON OR ABOUT 4/17/99. THE PT DENIED ANY SYMPTOMS AT THE VERMILION BORDER TREATMENT SITES. THE PHYSICIAN PRESCRIBED ELOCON TOPICAL CREAM. ON 5/25/99, THE PT WAS EXAMINED AND THE PHYSICIAN NOTED RED, RAISED "BUMPS" WITH PRURITIS AT THE NASOLABIAL FOLDS AND CHIN TREATMENT SITES. THE PHYSICIAN PRESCRIBED CLEOCIN TOPICAL CREAM. THE PHYSICIAN DIAGNOSED THE SYMPTOMS AS HYPERSENSITIVITY. ON 6/8/99 AND 7/13/99 THE PHYSICIAN INJECTED KENALOG INTRALESIONALLY AT THE TREATMENT SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 98M041A, 96D078E

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention