BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITLENG HOOK

    MDR report key: 5100054 · Received September 24, 2015

    Report

    Report Number
    5100054
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 22, 2015
    Manufacturer
    FCI OPHTHALMICS INC
    Product Code
    HNQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RITLENG HOOK WAS USED DURING A PROCEDURE TO PULL A STENT THROUGH NARES. WHEN THE HOOK WAS REMOVED IT WAS NOTED THAT THE TIP OF THE HOOK WAS MISSING. AN X-RAY WAS OBTAINED AND A SMALL OBJECT WAS NOTED IN THE IMAGE. THE MISSING TIP WAS FOUND AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631419 RITLENG HOOK HOOK, OPHTHALMIC HNQ FCI OPHTHALMICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR