BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 202052 · Received December 14, 1998

    Report

    Report Number
    2939859-1998-00302
    Event Type
    Injury
    Date Received
    December 14, 1998
    Date of Event
    December 13, 1994
    Report Date
    November 12, 1998
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO WAS TREATED IN THE NASOLABIAL CREASE AND WRINKLES ALONG THE JAWLINES ON 12/13/1994. ON 12/13/1994 THE PT DEVELOPED "PURPLE LINES WHERE COLLAGEN HAD BEEN INJECTED, APPEARED LIKE BRUISE. NO INTERVENTION WAS PRESCRIBED. IN 6/1997, THE SYMPTOMS WERE ONGOING; NO INTERVENTION WAS REQUIRED. THE PHYSICIAN SPOKE TO THE PT IN 9/1998; THERE WAS STILL SOME DISCOLOURATION PRESENT, ALTHOUGH MUCH LESS OBVIOUS THAN INITIALLY. NO INTERVENTION WAS REQUIRED. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 94E140

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability