BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW II

    MDR report key: 2033290 · Received March 28, 2011

    Report

    Report Number
    2033290
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    ACID WAS NOTED DRIPPING FROM THE BATTERY PACK OF THE IRRIGATOR.====================== MANUFACTURER RESPONSE FOR BATTERY OPERATED IRRIGATOR, IRRIGATOR======================THE SALES REPRESENTATIVE STATED THAT THEY THOUGHT THEY GOT ALL OF THE AFFECTED DEVICES REMOVED FROM SERVICE. EVIDENTLY THIS ONE CAME FROM A DISTRIBUTOR AND NOT DIRECTLY FROM STRYKER. HOWEVER, (B) (6) PURCHASED THESE ITEMS DIRECTLY FROM STRYKER. STRYKER REPLACED THE AFFECTED ITEMS THAT WERE PULLED FROM OUR SHELF WITH THE SAME LOT NUMBER AFTER THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW II BATTERY OPERATED IRRIGATOR FQH STRYKER INSTRUMENTS * 11026FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 *