BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI & WF

    MDR report key: 3070401 · Received April 17, 2013

    Report

    Report Number
    1920664-2013-00085
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE FOR INVESTIGATION. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED. REPORT 2 OF 2. SEE REPORT #1920664-2013-00084.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A CUTTER FAILURE. THEY WERE USING A CUTTER THAT STOPPED CUTTING, SO THEY WAITED AND IT STARTED AGAIN. THE SURGERY WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164947 STELLARIS 25GA POSTERIOR PACK W AFI & WF HQC BAUSCH & LOMB, INC. BL5425W UNK

    Patients

    Seq Age Sex Outcome Treatment
    1