BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRPLS HP W/BO CLEAN TIP S-TB

    MDR report key: 1935633 · Received December 14, 2010

    Report

    Report Number
    2648666-2010-00492
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR INVESTIGATION. WHEN THE DEVICE IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY STARTED TO SMELL LIKE IT WAS BURNING DURING A PROCEDURE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRPLS HP W/BO CLEAN TIP S-TB JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK