BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 246285 · Received October 20, 1999

    Report

    Report Number
    2939859-1999-00205
    Event Type
    Injury
    Date Received
    October 20, 1999
    Date of Event
    July 1, 1999
    Report Date
    August 17, 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 # 2939859-1999-00221 (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 DOUBLE SKIN TESTED ON 6/10/1999 AND ON 7/5/1990, (RIGHT AND LEFT FOREARMS), BOTH WITH NEGATIVE RESULTS. IN 1999, THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE UPPER VERMILION BORDER, NASOLABIAL FOLDS AND THE ORAL COMMISSURES. TWO DAYS LATER THE PT CALLED TO COMPLAIN THAT THE UPPER LIP WAS VERY SWOLLEN AND "PUFFY." BY THE TIME THE PT WAS SEEN (EXACT DATE NOT AVAILABLE), THE SWELLING HAD DIMINISHED, HOWEVER, THE PHYSICIAN NOTED WELTS IN THE UPPER NASOLABIAL FOLDS. THE RIGHT FOREARM TEST SITE WAS RED AND SWOLLEN. THE ORAL COMMISSURES WERE ASYMPTOMATIC. THE PHYSICAN DIAGNOSED HYPERSENSITIVITY AND PRESCRIBED ORAL BENADRYL. THE PT'S CONDITION IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP NA 98K151D

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention