BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA STOOL MANAGEMENT KIT

    MDR report key: 20203028 · Received September 11, 2024

    Report

    Report Number
    MW5159542
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 9, 2024
    Manufacturer
    CM TECHNOLOGIES, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRONGS OF RECTAL TUBE ARE POSSIBLE SECONDARY CAUSE OF RECTOVAGINAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506402 QORA STOOL MANAGEMENT KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CM TECHNOLOGIES, INC. MG22014002 132410

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization