BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM)

    MDR report key: 7480345 · Received May 2, 2018

    Report

    Report Number
    1222074-2018-00092
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    DUTCH OPTHALMIC RESEARCH CENTER BV
    Product Code
    MPA
    UDI-DI
    08717872021942
    PMA / PMN Number
    K062895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT REVEAL THE ROOT CAUSE, DUE TO SEVERE CONTAMINATION. SINCE IT IS CONTAINING SILICON DIRT, FOREIGN PARTICLES, CAN CAUSE FOREIGN BODY REACTION TO PATIENT, HENCE IT IS CONCLUDED AS REPORTABLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER (B)(4) DETAILS OF THIS ACTIVITY WERE DISCUSSED WITH CDRH OFFICE OF COMPLIANCE (B)(4) ) DURING A TELE-CONFERENCE ON (B)(4) 2017. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED. THIS COMPLAINT HAS NOW BEEN CLOSED.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED OF AN EVENT THAT OCCURRED IN (B)(6): THERE HAVE BEEN TWO PARTICLES WHICH ARE PROBABLY FROM THE SILICON MEDICAL GRADE. IT`S DIFFICULT TO RECOGNIZE AT THE PHOTOS BUT WE COULD DEFINITELY SEE THEM. SHE TRIED TO SAVE THEM BUT THEY HAVE BEEN TOO THIN SO WE LOST THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321361 DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM) DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM) MPA DUTCH OPTHALMIC RESEARCH CENTER BV 2000368813 08717872021942

    Patients

    Seq Age Sex Outcome Treatment
    1