BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 260835 · Received February 2, 2000

    Report

    Report Number
    2939859-2000-00006
    Event Type
    Injury
    Date Received
    February 2, 2000
    Date of Event
    October 26, 1999
    Report Date
    January 5, 2000
    Manufacturer
    MCGHAN MEDICAL CORP. (FREMONT)
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 2939859-2000-00005 (COLLAGEN CORP #1026377). 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 FDA'S REQUEST FOR TRACEABILITY PURPOSES. PHYSICIAN REPORTED A PT WHO WAS SKIN TESTED WITH A COLLAGEN TEST IMPLANT IN 1999 WITH NEGATIVE RESULTS. PT WAS THEN TREATED IN 1999 WITH A FORMULATION OF THE PRODUCT IN THE GLABELLA AND A SECOND FORMULATION IN THE NASOLABIAL FOLDS. THE PT DEVELOPED RED LINES WHERE THE COLLAGEN WAS PLACED IN THE NASOLABIAL FOLDS AS WELL AS A LUMP AT THE LOWER LEFT NASOLABIAL FOLD. THERE WAS GENERALIZED ERYTHEMA IN THE GLABELLAR AREA. A RE-SKIN TEST WAS DONE. PT WAS STARTED ON ORAL ANTIHISTAMINES AND STEROID CREAM. ACCORDING TO THE PHYSICIAN, "PRODUCT BROKE DOWN QUICKLY AS OF 9 NOV 99." THE TEST SITES DEVELOPED NO SYMPTOMS. THE PHYSICIAN CONSIDERED THE LOCAL SYMPTOMS TO BE PRODUCT RELATED. NO SYSTEMIC SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT LMH MCGHAN MEDICAL CORP. (FREMONT) NA 99D061C

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention