BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSERTION TUBES

    MDR report key: 1784236 · Received July 29, 2010

    Report

    Report Number
    3005677147-2010-00006
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A WRONG PRODUCT SHIPPED ERROR. NO SURGERY DELAYS OR PATIENT INJURIES WERE NOTED DUE TO THIS ISSUE. TUBES WERE SHIPPED FOR THE MICROTARGETING DRIVE WHEN THE SURGEON WAS TO HAVE USED THE STAR DRIVE AND THEIR ASSOCIATED TUBES. USE OF THE STAR DRIVE WAS ABANDONED PRIOR TO THE SURGERY DUE TO THE SURGEON'S PREFERENCE.

    Description of Event or Problem · 1

    DISTRIBUTOR SALES REPRESENTATIVE REPORTED TO FHC PRODUCT MANAGER THAT UPON REVIEWING THE CONSUMABLES THE HOSPITAL HAD JUST RECEIVED FROM FHC, FOUND A BOX OF INSERTION TUBES AND QUESTIONED THE CATALOG NUMBER. THE TUBES SENT WERE 7 MM LONGER THAN THE ONES ORDERED. NO SURGERY DELAY OR PATIENT IMPACT RESULTED FROM SHIPMENT OF THE INCORRECT TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTION TUBES INSERTION TUBES HAW FHC, INC. 558531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MICROTARGETING STAR DRIVE SYSTEM