BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 200186 · Received December 2, 1998

    Report

    Report Number
    2939859-1998-00292
    Event Type
    Injury
    Date Received
    December 2, 1998
    Date of Event
    July 21, 1998
    Report Date
    November 4, 1998
    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 PATIENT REPORTED UNDER MFR ID #2939859-1998-00293, (COLLAGEN CORPORATION #1023813). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT. A PHYSICIAN REPORTED A PATIENT WHO WAS ORIGINALLY SKIN TESTED (DATE UNKNOWN) WITH NEGATIVE RESULTS. ON 21 JULY 1998, THE PATIENT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE ORAL COMMISSURES. ON 21 OCTOBER 1998, THE PATIENT WAS EXAMINED AND THE PHYSICIAN NOTED MODERATE ERYTHEMA AND INDURATION AT THE TREATMENT SITES. THE PATIENT STATED SHE HAD THE SYMPTOMS SINCE THE DAY OF THE TREATMENT. THE PHYSICIAN PRESCRIBED BENADRYL CREAM 2%. THE PHYSICIAN ALSO PRESCRIBED ORAL KEFLEX IN CASE OF A SECONDARY INFECTION, ALTHOUGH NO SYMPTOMS OF INFECTION WERE NOTED. THE PHYSICIAN BELIEVED THIS IS A DEFINITE HYPERSENSITIVITY TO THE COLLAGEN. NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS PLANNED OR PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 97K081A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention VITAMINS (UNK TO 11/04/1998).