BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO INTPLS HP W/10' SUCT TUBE

    MDR report key: 2896470 · Received November 20, 2012

    Report

    Report Number
    2648666-2012-00362
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 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

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DEVICES OVERHEATED DURING THE COURSE OF A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REPORTED. A BACK-UP DEVICE WAS USED WITHOUT SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO INTPLS HP W/10' SUCT TUBE FQH STRYKER INSTRUMENTS PUERTO RICO 12144012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(4) (EURO INTPLS HP W/10