BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST SYSTEM ROTARY VANE DOMESTIC

    MDR report key: 231034 · Received June 17, 1999

    Report

    Report Number
    2023366-1999-00024
    Event Type
    Injury
    Date Received
    June 17, 1999
    Date of Event
    May 19, 1999
    Report Date
    May 19, 1999
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE CATALYST UNIT DELIVERED INTERMITTENT POWER, THEN MAXIMUM POWER. A CAPSULAR TEAR OCCURRED AND A VITRECTOMY PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATALYST SYSTEM ROTARY VANE DOMESTIC EQUIPMENT HQC CHIRON VISION CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention