BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE

    MDR report key: 7650686 · Received June 29, 2018

    Report

    Report Number
    0001932402-2018-00004
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 8, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NGY
    UDI-DI
    20841305111374
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 7 SEE: 1932402-2018-00005, 00006, 00007, 00008, 00009, 00010.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED ENDOPHTHALMITIS AFTER A PROCEDURE IN WHICH BAUSCH + LOMB DEVICES WERE USED. THE CAUSE OF THE ENDOPHTHALMITIS HAS NOT BEEN DETERMINED. ADDITIONAL INFORMATION REGARDING POSSIBLE TREATMENT AND PATIENT OUTCOME HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493551 SYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE 27GA VALVED ESA SYSTEM NGY BAUSCH + LOMB BL5240 M0013382 20841305111374

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention