BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 126288 · Received October 10, 1997

    Report

    Report Number
    2939859-1997-00220
    Event Type
    Injury
    Date Received
    October 10, 1997
    Date of Event
    June 1, 1996
    Report Date
    September 25, 1997
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 3/3/1998, FOLLOW UP INFO WAS RECEIVED. THE SYMPTOMS RESOLVED IN APPROX 9/1997. EXTRA STRENGTH TYLENOL WAS PRESCRIBED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO WAS TREATED WITH TWO FORMULATIONS OF COLLAGEN ON 5-15 1996 IN THE NASOLABIAL FOLDS AND UPPER VERMILION BORDER. IN 6/1996 (EXACT DATE UNK), THE PT DEVELOPED INTERMITTENT SWELLING AT THE UPPER VERMILION BORDER ONLY. THE PT WAS SEEN ON 8-7 1996 WITH SWELLING AT THE UPPER VERMILION BORDER. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY. ON 9-25 1997, THE PHYSICIAN REPORTED THAT HE PRESCRIBED AN ORAL ANTIHISTAMINE (DATE UNK) AND ISNTRUCTED THE PT TO LIMIT THE USE OF COFFEE, TEA AND ALCOHOL. IN 8/1997, THE SYMPTOMS WERE ONGOING BUT BECOMING LESS AS TIME WENT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 96B033B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention PREMARIN (UNK TO UNK)