BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION ONLY TIP

    MDR report key: 2941976 · Received December 21, 2012

    Report

    Report Number
    2648666-2012-00387
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT WOULD NOT STAY CONNECTED TO THE DEVICE DURING PREPARATION FOR USE. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRRIGATION ONLY TIP FQH STRYKER INSTRUMENTS PUERTO RICO 11194012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention