BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOBBHOFF FEEDING TUBE

    MDR report key: 139875 · Received December 26, 1997

    Report

    Report Number
    1314412-1997-00031
    Event Type
    Malfunction
    Date Received
    December 26, 1997
    Report Date
    November 28, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. COMPLAINT #OV1997-8-7-44 COMPLAINT REPORT NUMBER WAS CHANGED FROM 1034525-1997-00004 TO 1314412-1997-00031, BECAUSE THE PLANT OF MFR WAS MIDIDENTIFIED. THIS PRODUCT WAS NOT PRODUCED BY BIOSEARCH, INC. BUT RATHER BY THE ORISKANY FALLS NY PLANT OF SHERWOOD DAVIS AND GECK. REPORTING NUMBER HAS BEEN CHANGED TO CORRECTLY IDENTIFY THE MFG LOCATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, "DOBBHOFF TUBE WENT INTO PT'S LUNG. NO RESISTANCE BY PT; [PT] WAS SWALLOWING." FEEDING TUBE IN LUNG WAS CONFIRMED BY X-RAY. A CHEST TUBE WAS PLACED DUE TO PNEUMOTHORAX. NO FURTHER CONSEQUENCES WERE EXPERIENCED. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOBBHOFF FEEDING TUBE FEEDING TUBE KNT SHERWOOD DAVIS AND GECK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention