BEUDAMED
    FDA Adverse Event Summary report: N

    OBWEGESER NASAL OSTEO,18.5CM

    MDR report key: 1632731 · Received March 16, 2010

    Report

    Report Number
    1032347-2010-00028
    Date Received
    March 16, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 18, 2010
    Product Code
    HWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT FROM THE HOSPITAL. STATED PATIENT TAKEN TO OR FOR LEFORT I PROCEDURE. DURING THE PROCEDURE A NASAL SEPTAL CHISEL WAS USED TO OSTEOTOMIZE THE NASAL SEPTUM. AFTER THE NASAL SEPTAL WAS USED, IT WAS NOTED THAT THE ANTERIOR FOURTH PORTION WAS MISSING. C ARM WAS BROUGHT INTO THE ROOM AND THE CHISEL FRAGMENT WAS LOCATED IN THE NASAL ON THE RIGHT SIDE. THE CHISEL PIECE WAS REMOVED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBWEGESER NASAL OSTEO,18.5CM OSTEOTOME HWM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention