BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT

    MDR report key: 179247 · Received July 9, 1998

    Report

    Report Number
    2939859-1998-00169
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    May 22, 1998
    Report Date
    June 17, 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 PT REPORTED UNDER MDR ID # 2939859-1998-00168. 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 WAS ORIGINALLY SKIN TESTED ON 9 APRIL 1998 WITH NEGATIVE RESULTS. ON 20 MAY 1998, THE PT WAS TREATED WITH TWO FORMULATIONS OF COLLAGEN IN THE NASOLABIAL FOLDS, GLABELLA, AND THE VERTICAL LIP LINES ABOVE THE UPPER VERMILION BORDER. ON 22 MAY 1998, THE PT DEVELOPED A LARGE, RED, RAISED, AND "ITCHY" RASH AROUND THE MOUTH AND DOWN THE CHIN- "IN A RING-LIKE SHAPE" INCLUDING BOTH COLLAGEN TREATED AND NON-TREATED AREAS. NO DIFFERENTIATING SYMPTOMS WERE NOTED AT THE COLLAGEN TREATED SITES. THE PT ALSO DEVELOPED A RED, RAISED RASH ON HER EYELIDS, "ITCHY" SCALP AND "DRY" SKIN ON HER FACE. THE PT WAS TREATED WITH A LASER FOR HAIR REMOVAL IN THE SAME AREA AS PERIORAL RASH ABOUT 1 MO PRIOR TO COLLAGEN TREATMENT. ON 17 JUNE 1998, THE PT WAS EXAMINED AND THE SYMPTOMS CONTINUED. THE PHYSICIAN PRESCRIBED HYDROCORTISONE CREAM AND ORAL BENADRYL. THE PHYSICIAN BELIEVED THE SYPMTOMS MAY POSSIBLY BE A HYPERSENSITIVITY TO COLLAGEN, OR A POSSIBLE ADVERSE RESPONSE TO THE PRIOR LASER TREATMENT. NO FURTHER MED OR SURGICAL INTERVENTION WAS PLANNED OR PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 97L152A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 3. TAMOXIFEN (UNK TO 05/20/1998).| 2. TIMOPTIC (UNK TO 05/20/1998).| 1. PREMARIN (UNK TO 05/20/1998).| 4. LASER TREATMENT (04/1998 TO 05/20/1998).