BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE DRIVER/ EXTRACTOR/ HXJ

    MDR report key: 1335102 · Received March 5, 2009

    Report

    Report Number
    1020279-2009-00510
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    January 27, 2009
    Report Date
    March 2, 2009
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    HXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FRACTURED DURING REMOVAL OF THE STAPLE AND PART OF THE DEVICE WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAPLE DRIVER/ EXTRACTOR/ HXJ HXJ BROOKS MANUFACTURING SITE TBL FIX STPL DRVR-EXTRAC HT05001

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other