BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSS

    MDR report key: 4244863 · Received November 4, 2014

    Report

    Report Number
    1421101-2014-00001
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    November 3, 2014
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DATE OF EVENT UNKNOWN. THIS IS NOT A SINGLE USE DEVICE. CLASS 1 EXEMPT. THE ACTUAL DEVICE WAS REVIEWED. A DHR REVIEW WAS ALSO CONDUCTED AND THERE WERE NO DEVIATIONS NOTED. MFR DATE: 11/2013.

    Description of Event or Problem · 1

    TIP BROKE DURING SURGERY ON PEDIATRIC PATIENT. SURGEON COULD NOT RETRIEVE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707884 BOSS OVAL WINDOW PICK, .33MM PT ANG 90DEG LRC INSTRUMED INTERNATIONAL, INC. 020213 / 110213

    Patients

    Seq Age Sex Outcome Treatment
    1