BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION DISTAL END CUTTERS

    MDR report key: 1600528 · Received February 3, 2010

    Report

    Report Number
    2086211-2010-00010
    Event Type
    Injury
    Date Received
    February 3, 2010
    Date of Event
    September 24, 2009
    Report Date
    January 8, 2010
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    EJB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE A SERIOUS INJURY RESULTED IN THIS CASE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A PAIR OF OVATION CUTTERS SEPARATED DURING USE AND WAS ASPIRATED BY THE PT. THE PIECE WAS RETRIEVED BY MEANS OF AN ENDOSCOPIC PROCEDURE AND THE PT STAYED IN THE HOSP OVERNIGHT FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATION DISTAL END CUTTERS EJB GAC INTERNATIONAL NA 00-26

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R 16X22 STAINLESS STEEL WIRE