BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITRASERT IMPLANT

    MDR report key: 43257 · Received October 17, 1996

    Report

    Report Number
    MW4001652
    Event Type
    Injury
    Date Received
    October 17, 1996
    Date of Event
    September 17, 1996
    Report Date
    September 24, 1996
    Manufacturer
    CHIRON VISON
    Product Code
    HQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHITE PAPER OVERWRAP ON IMPLANT HAD ADHERED TO DRUG IMPLANT WHEN OPENED. APPEARED TO BE LEAKAGE ON PAPER AND FROM IMPLANT WHEN VIEWED UNDER MICROSCOPE BY PHYSICIAN/SURGEON. RETURNED THE INVOLVED PRODUCT TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITRASERT IMPLANT Implant INTRAVITREAL GANCICLOVIR-FREE ACID IMPLANT HQJ CHIRON VISON * QR000005

    Patients

    Seq Age Sex Outcome Treatment
    1 *