BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 1625743 · Received February 22, 2010

    Report

    Report Number
    9616696-2010-00186
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    July 29, 2009
    Report Date
    July 29, 2009
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT CAN BE CONFIRMED FROM VISUAL INSPECTION THAT PRODUCT PACKAGING IS DAMAGED. OTHER COMPLAINTS HAVE BEEN RECEIVED REPORTING SIMILAR EVENTS. AN ALTERNATIVE PACKAGING MATERIAL HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT PACKAGING WAS BRITTLE. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CUT SAGITTAL BLADE SAW BLADES AND ACCESSORIES DWH STRYKER IRELAND LTD. 04121507

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK