BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANNULOFLEX RING

    MDR report key: 1232550 · Received November 9, 2008

    Report

    Report Number
    1232550
    Event Type
    Malfunction
    Date Received
    November 9, 2008
    Date of Event
    September 12, 2008
    Report Date
    November 9, 2008
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A DOCTOR REQUESTED A CARBOMEDICS ANNULOFLEX RING SIZE 30MM. UPON OPENING THE IMPLANT, THE CIRCULATING NURSE AND SCRUB NURSE CONFIRMED THE SERIAL NUMBERS ON THE IMPLANT AND ON PRODUCT PACKAGING AND LABELS. ALL NUMBERS ON THE PAPERWORK INDICATE ONE NUMBER BUT THE TAG SERIAL NUMBER ATTACHED TO THE IMPLANT INDICATES A SERIAL NUMBER THAT IS ONE DIGIT OFF FROM THE SERIAL NUMBER ON THE PAPERWORK. WHEN THE SERIAL NUMBERS WERE NOT A MATCH, THE SCRUB NURSE ASKED THE PHYSICIAN ASSISTANT TO CHECK THE NUMBERS. THE PHYSICIAN ASSISTANT ALSO INDICATED THAT THE NUMBERS DID NOT MATCH. THE DOCTOR WAS NOTIFIED AND ELECTED TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANNULOFLEX RING IMPLANT, MITRAL VALVE KRH CARBOMEDICS, INC. AF-830 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR