BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISIMPACTOR

    MDR report key: 12632444 · Received October 13, 2021

    Report

    Report Number
    MW5104576
    Event Type
    Death
    Date Received
    October 13, 2021
    Date of Event
    August 22, 2021
    Report Date
    October 7, 2021
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP (F/K/A CENTURION MEDICAL PRODUCTS CORPORATION)
    Product Code
    KDC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CENTURION DISIMPACTOR DEVICE WAS USED FOR IMPACTED STOOL, THE DEVICE LED TO A RECTAL PERFORATION WHICH LED TO GI HEMORRHAGE AND ULTIMATELY THE PATIENT'S DEATH. LARGE BOWEL: AXIAL IMAGE 161/2 DEMONSTRATES A 15 MM HIGH DENSITY OVOID FOCUS AT APPROXIMATELY THE 1:30 POSITION WITHIN THE RECTAL WALL. DENSITY IS IDENTICAL TO THAT WITHIN ARTERIAL LUMINA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526310 DISIMPACTOR INSTRUMENT, SURGICAL, DISPOSABLE KDC CENTURION MEDICAL PRODUCTS, LP (F/K/A CENTURION MEDICAL PRODUCTS CORPORATION)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| O