BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PICO SYSTEM

    MDR report key: 8903920 · Received August 16, 2019

    Report

    Report Number
    9615010-2019-00010
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 18, 2019
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    FSO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PICO DEVICE PULLED AWAY FROM THE WALL AND DID NOT SIT LEVEL. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695072 OPMI PICO SYSTEM OPMI PICO FSO CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1