BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE PASS PEG KIT, 20 FR

    MDR report key: 132094 · Received November 14, 1997

    Report

    Report Number
    2242547-1997-00020
    Event Type
    Death
    Date Received
    November 14, 1997
    Report Date
    October 17, 1997
    Manufacturer
    BIOSEARCH MEDICAL PRODUCTS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN OCCURRENCE OF PERITONITIS THAT RESULTED IN DEATH. THE DOCTOR CANNOT DIRECTLY LINK THE PEG TO THE CAUSE OF DEATH (PT WAS IN BAD SHAPE TO BEGIN WITH) BUT ESTABLISHED LEAKAGE. NO FURTHER DETAILS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE PASS PEG KIT, 20 FR PEG KIT KNT BIOSEARCH MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death