BEUDAMED
    FDA Adverse Event Death Summary report: N

    30-1834- BUTTON

    MDR report key: 147457 · Received February 6, 1998

    Report

    Report Number
    1526012-1998-00001
    Event Type
    Death
    Date Received
    February 6, 1998
    Date of Event
    January 25, 1998
    Report Date
    February 2, 1998
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORPAK PEG- 12FR (INITIALLY IMPLANTED 6/97) WAS REPLACED WITH A 30-1834 (18FR 3.4CM BUTTON) ON 1/23/98. PT DIED ON 1/25/98. POSTMORTEM INDICATED STOMA DID NOT HAVE STRONG ADHESION TO ABDOMEN. FEED HAD GONE INTO PERITONEUM, RESULTING IN DEATH. NO FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30-1834- BUTTON Implant REPLACEMENT GASTROSTOMY FEEDING BUTTON KNT APPLIED MEDICAL TECHNOLOGY, INC. 18FR 3.4CM BUTTON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death