BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDP

    MDR report key: 1442657 · Received August 19, 2009

    Report

    Report Number
    3005075853-2009-02074
    Event Type
    Malfunction
    Date Received
    August 19, 2009
    Date of Event
    March 12, 2009
    Report Date
    March 16, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FDP
    PMA / PMN Number
    K910875
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THEY COULD NOT GET AIR OR FLUID THRU THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FDP FDP ETHICON ENDO-SURGERY, LLC. NA E4MA4K

    Patients

    Seq Age Sex Outcome Treatment
    1