BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL

    MDR report key: 14521737 · Received May 27, 2022

    Report

    Report Number
    14521737
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 3, 2022
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TIP OF SHEATH CRIMPING ON ATTEMPTED INSERTION. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764101 STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL INTRODUCER, CATHETER DYB FREUDENBERG MEDICAL, LLC SS085075M 0000199475

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA Unknown