BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W FF

    MDR report key: 3193143 · Received June 25, 2013

    Report

    Report Number
    1920664-2013-00149
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 2 SEE 1920664-2013-00150.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE CUTTER WOULD NOT PERFORM DURING SURGERY. A BACK UP PACK WAS OPENED AND THEY PROCEEDED WITH THE SURGERY. THERE WAS PT CONTACT BUT NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286895 STELLARIS 25GA POSTERIOR PACK W FF HQC BAUSCH & LOMB, INC. BL5225 V0219

    Patients

    Seq Age Sex Outcome Treatment
    1