BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING

    MDR report key: 1031715 · Received April 15, 2008

    Report

    Report Number
    6000002-2008-06534
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS; HOWEVER, THE REASON FOR EXPLANT IS UNK. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY. INFO RECEIVED ON 04/01/2008: DEVICE WAS EXPLANTED DUE TO REGURGITATION. IT IS UNK IF THE DEVICE IS AVAILABLE FOR RETURN. INFO RECEIVED PER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4100M26 R-07K1958

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention