BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 211000 · Received February 19, 1999

    Report

    Report Number
    2939859-1999-00040
    Event Type
    Injury
    Date Received
    February 19, 1999
    Date of Event
    January 1, 1997
    Report Date
    January 29, 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

    A PHYSICIAN REPORTED A PT WHO WAS ORIGINALLY SKIN TESTED BY ANOTHER PHYSICIAN IN 10/1996 AND BY THE REPORTING PHYSICIAN IN 11/1996; BOTH WITH NEGATIVE RESULTS. ON 1/23/1997, THE PHYSICIAN TREATED THE PT IN THE NASOLABIAL FOLDS, ORAL COMMISSURES, AND THE VERMILION BORDERS AND THE VERMILION. ON 3/4/1997, THE PT RETURNED WITH A "LITTLE WHITE BEADING" ACROSS THE UPPER VERMILION. THE EXACT DATE OF SYMPTOM ONSET WAS NOT KNOWN. THE PHYSICIAN INSERTED A NEEDLE INTO THE BEADED AREAS AND EXPRESSED THE COLLAGEN OUT, IN ORDER TO SMOOTH OUT THE APPEARANCE OF THE VERMILION. THE PT RETURNED ON 3/11/1997 FOR TOUCH UP TREATMENT IN ALL SITES PREVIOUSLY TREATED. THE PHYSICIAN STATED THE TREATMENT WAS UNEVENTFUL, THERE WAS NO PT COMPLAINT AFTER THE SECOND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 96D070A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention