BEUDAMED
    FDA Adverse Event Other Summary report: N

    KATENA

    MDR report key: 1344489 · Received February 26, 2009

    Report

    Report Number
    2242450-2009-00001
    Event Type
    Other
    Date Received
    February 26, 2009
    Product Code
    HND
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF MED-WATCH REPORT FROM FDA - MFR CONTACTED USER FACILITY TO INQUIRE OF REPORTED EVENT. VERBALLY CONFIRMED FROM USER FACILITY RISK MANAGEMENT DEPARTMENT PERSONNEL THAT "NO INJURY TO PT WAS REPORTED BY THE DOCTOR." ALSO CONFIRMED THAT THE DEVICE WOULD BE AVAILABLE FOR MFR ASSESSMENT IN APPROX 2-4 WEEKS. AS OF THE DATE OF THIS REPORT, THE DEVICE IS REPORTEDLY GOING TO BE RETURNED FOR MFR EVAL BUT, HAS NOT BEEN RECEIVED. BASED ON THIS, THE SUBJECT DEVICE HAS NOT BE EVALUATED BY THE MFR. IF SUBJECT DEVICE IS MADE AVAILABLE TO MFG, A FOLLOW-UP MED-WATCH REPORT WILL BE FILED WITH ANY EVAL RESULTS. REVIEW OF MFR COMPLAINT HANDLING SYSTEM DATABASE CONFIRMS THIS IS THE FIRST REPORT OF THIS NATURE FOR THIS DEVICE (K3-2398). DEVICE HAS BEEN IN COMMERCIAL DISTRIBUTION SINCE 12/1994. EXAMINATION OF A REPRESENTATIVE SAMPLE FOUND NO ABNORMALITIES THAT COULD CAUSE TO PRODUCT FAILURE DURING INTENDED USE AND HANDLING SCENARIOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KATENA ROWEN PHACO SPATULA, DOUBLE-ENDED HND NA

    Patients

    Seq Age Sex Outcome Treatment
    1