BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1020341 · Received March 27, 2008

    Report

    Report Number
    6000002-2008-06361
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention