BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROSS LABS

    MDR report key: 528899 · Received February 19, 2004

    Report

    Report Number
    528899
    Event Type
    Death
    Date Received
    February 19, 2004
    Date of Event
    August 25, 2003
    Report Date
    February 19, 2004
    Manufacturer
    ROSS LABS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD CHANGED G-TUBE. ABOUT 20" LATER PT IN SEVERE PAIN UNRELIEVED BY ORAL ANALGESIC. PT WAS GIVEN MS 2MG. 3HOURS LATER, "NOT DOING WELL, TEMP 102." TRANSFERRED TO ACUTE FACILITY. UNDERWENT SURGERY WHERE "PERITONITIS" AND CLOUDY FLUID CONSISTENT WITH TUBE FEEDING WAS FOUND. DIED 9/2003.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/2/04: NO FURTHER INFO HAS BEEN RECEIVED. PLEASE NOTE THAT THE LOT NUMBER PROVIDED IN THE VOLUNTARY REPORT IS AN INVALID LOT NUMBER. THE LOT NUMBER REPORTED TO ROSS WAS 95-396-GZ, AS INDICATED IN ITS INITIAL MDR. NO FAILURE ANALYSIS OR LAB TESTING WAS POSSIBLE AS THE DEVICE HAD BEEN DISCARDED. ATTACHED TO THIS LETTER IS THE REPORT SUBMITTED TO ROSS BY THE FACILITY RISK MANAGER. THIS INFO INDICATES THE DEVICE DID NOT FAIL. IT DOES INDICATE TUBE PLACEMENT WAS NOT CONFIRMED BY X-RAY, AND THE PLACEMENT WAS DIFFICULT. SEE 2 ABOVE. THE CONCLUSION CODES SUBMITTED IN ORIGINAL MDR WERE 70 (DEVICE DISCARDED -UNABLE TO FOLLOW UP) AND 67 (NO CONCLUSION CAN BE DRAWN). THE REPORTER INDICATED TO ROSS THAT THE DEVICE WAS NOT AVAILABLE FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS LABS G-TUBE KNT ROSS LABS 20 FR. FLEXI-FLOW WITH 15CC BALLOON INFLATION 95396GZ00

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| H| O| R