BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT

    MDR report key: 246264 · Received October 20, 1999

    Report

    Report Number
    2939859-1999-00220
    Event Type
    Injury
    Date Received
    October 20, 1999
    Date of Event
    December 5, 1997
    Manufacturer
    COLLAGEN CORP
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 2939859-1999-00218 (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 PT WHO WAS SKIN TESTED ON 9/13/1997 WITH NEGATIVE RESULTS. IN 1997, THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE VERMILLION BORDERS, NASOLABIAL FOLDS, AND ORAL COMMISSURES. IN 1997, THE PT NOTICED REDNESS AND SWELLING AT THE TREATMENT SITES WHICH RESOLVED IN 1998. THE LOCAL SYMPTOMS WERE CONSIDERED BY THE PHYSICIAN TO BE PRODUCT RELATED. THE PT WAS PRESCRIBED ORAL DEXAMETHASONE IN 1997 WHICH WAS EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP NA 96L229A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention