BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI & WF

    MDR report key: 3040475 · Received April 3, 2013

    Report

    Report Number
    1920664-2013-00053
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD THE DEVICE BECOME AVAILABLE FOR INVESTIGATION. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6). THE CUTTER STOPPED MOVING DURING SURGERY. THE SURGEON MOVED HIS FOOT FROM THE CONTROLLER AND AGAIN PEDALED. THE CUTTER WORKED AND COMPLETED THE SURGERY. IT IS UNK IF THE ASPIRATION CONTINUED WHILE THE CUTTER STOPPED MOVING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135985 STELLARIS 25GA POSTERIOR PACK W AFI & WF HQC BAUSCH & LOMB, INC. BL5525W U8875

    Patients

    Seq Age Sex Outcome Treatment
    1