BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAGEN 2MM X 2CM 1 UNIT

    MDR report key: 787916 · Received December 20, 2004

    Report

    Report Number
    1121308-2004-00056
    Event Type
    Other
    Date Received
    December 20, 2004
    Report Date
    December 20, 2004
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    FZX
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO DEVICE MALFUNCTION WAS REPORTED, THE PATIENT'S SURGICAL TREATMENT WAS DELAYED DUE TO THE MIS-SHIPMENT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED CUSTOMER SERVICE TO INQUIRE ABOUT THE DELIVERY STATUS OF ORDER THAT INCLUDED VARIOUS NEURAGEN SIZES; INCLUDING PRODUCT NUMBERS PNG220; PNG320; PNG420: PNG520 AND PNG620. CUSTOMER SERVICE TRACKED THE SHIPMENT THROUGH FEDERAL EXPRESS, AND WAS ADVISED BY THE RENO DISTRIBUTION CENTER THAT FEDERAL EXPRESS LOST THE SHIPMENT. ACCORDING TO FEDERAL EXPRESS, THEY DON'T HAVE IT. SURGERY WAS SCHEDULED FOR 4:00PM ON NOVEMBER 24, 2004. THE CUSTOMER WAS REFERRED TO THEIR NEUROSPECIALIST. A REPLACEMENT SHIPMENT WAS PROCESSED UNDER SALES ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAGEN 2MM X 2CM 1 UNIT NEURAGEN FZX INTEGRA LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other