BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE 1

    MDR report key: 198368 · Received November 19, 1998

    Report

    Report Number
    2939859-1998-00282
    Event Type
    Injury
    Date Received
    November 19, 1998
    Date of Event
    October 27, 1998
    Report Date
    November 9, 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# 2939859-1998-00281, (COLLAGEN CORP # 1023763). 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 THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. A PHYSICIAN REPORTED A PT WHO WAS ORIGINALLY SKIN TESTED ON 16 SEPTEMBER 1998 WITH NEGATIVE RESULTS. ON 23 OCTOBER 1998, THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE PERIORBITAL AREAS (FINE LINES AT CORNER OF BOTH EYES AND JUST BELOW FOLD OF LOWER EYELID); AND AT THE CUPID'S BOW AND BOTH ORAL COMMISSURES. ON 27 OCTOBER 1998 THE PT WAS EXAMINED AND THE PHYSICIAN NOTED THAT ALL THE TREATMENT SITES WERE SLIGHTLY RED WITH SWELLING EVIDENT AT THE ORAL COMMISSURES AND LOWER EYELID AREA. THE PT NOTED ITCHING AT THE LOWER EYELID TREATED AREA ONLY. ON 27 OCTOBER 1998, THE PHYSICIAN PRESCRIBED TOPICAL TEMOVATE CREAM. ON 30 OCTOBER 1998 THE PT PRESENTED WITH DECREASED SWELLING. THE PT WAS ADVISED TO USE ORAL BENADRYL. ON 6 NOVEMBER 1998 THE SYMPTOMS CONTINUED. THE PHYSICIAN DIAGNOSED A "QUESTIONABLE" HYPERSENSITIVITY TO COLLAGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 1 Implant GAX LMH COLLAGEN CORP. NA 97A031C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 1. CLARITIN (UNK TO 10/23/1998).| 2. VANCENASE (UNK TO 10/23/1998).