BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEIBEL CHOPPER

    MDR report key: 3272590 · Received August 2, 2013

    Report

    Report Number
    MW5031314
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    July 22, 2013
    Report Date
    August 2, 2013
    Manufacturer
    RHEIN MEDICAL INC.
    Product Code
    HNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A CATARACT SURGERY, WHEN THE SEIBEL CHOPPER TIP BROKE OFF IN THE PATIENT'S EYE. THE SURGEON RETRIEVED THE BROKEN PIECE OUT OF THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363185 SEIBEL CHOPPER HNQ RHEIN MEDICAL INC. 14562

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention