BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN GI

    MDR report key: 16379058 · Received February 15, 2023

    Report

    Report Number
    9612030-2023-03546
    Event Type
    Death
    Date Received
    February 15, 2023
    Report Date
    February 15, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    <P>THIS COMPLAINT WAS RECEIVED VIA AN ANONYMOUS CLINICAL STUDY.&NBSP; SAMPLE ANALYSIS COULD NOT BE PERFORMED SINCE SAMPLES WERE NOT PROVIDED FOR EVALUATION. THIS COMPLAINT WILL BE USED FOR TRENDING AND POST MARKET ANALYSIS.&NBSP; </P>

    Description of Event or Problem · 0

    PER A POST MARKET CLINICAL SURVEY, THE CUSTOMER OBSERVED A DEATH WITH THE USE OF A SALEM SUMP DEVICE. THE CUSTOMER STATED THERE WAS A ¿PROBABLE DEVICE RELATIONSHIP¿. THIS INFORMATION WAS RECEIVED VIA AN ANONYMOUS CLINICAL STUDY; THEREFORE, THE CUSTOMER INFORMATION IS UNKNOWN AND NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126797 UNKNOWN GI TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG CARDINAL HEALTH UNKNOWN GI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death