BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANGUIDE

    MDR report key: 12083431 · Received June 29, 2021

    Report

    Report Number
    12083431
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 22, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLEANGUIDE¿ DISPOSABLE MARKED SPRING TIP GUIDEWIRE BENT WHILE DILATING WITH A SAVARY-GILLIARD HOLLOW-CENTERED DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981665 CLEANGUIDE BRUSH, BIOPSY, GENERAL PLASTIC SURGERY GEE CONMED CORPORATION 000150 2021085174

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA