BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM 23GA PROCEDURAL PACKS

    MDR report key: 2191902 · Received July 22, 2011

    Report

    Report Number
    1920664-2011-00099
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K020911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED SHOULD THE DEVICE BECOME AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM BRAZIL STATING DURING POST-OP THE VITRECTOMY GAUGE WAS RELEASED AND ALMOST HAPPENED DURING SURGERY. THE REPORT INDICATES NO PT INJURY OR REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM 23GA PROCEDURAL PACKS HQC BAUSCH & LOMB, INC. CX6923 U4029

    Patients

    Seq Age Sex Outcome Treatment
    1