BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    FLEXOR RAABE 5.0X38X55

    MDR report key: 16120807 · Received January 9, 2023

    Report

    Report Number
    16120807
    Event Type
    No answer provided
    Date Received
    January 9, 2023
    Date of Event
    February 6, 2021
    Report Date
    December 19, 2022
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RETAINED FOREIGN BODY LOCATED ON CT SCAN THIS ADMISSION IN THE LEFT GROIN SUSPECTED FROM A PROCEDURE IN (B)(6) 2021. DISCLOSED TO PATIENT BY MEDICAL TEAM AND PATIENT LEFT AMA (AGAINST MEDICAL ADVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564682 FLEXOR RAABE 5.0X38X55 INTRODUCER, CATHETER DYB COOK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown