BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PHYSIO II ANNULOPLASTY RING

    MDR report key: 2090266 · Received May 16, 2011

    Report

    Report Number
    2015691-2011-15542
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD (B)(4) - OTHER - THE SUBJECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: THE REASON FOR EXPLANT IS UNKNOWN. THE OPERATIVE REPORT AND PATIENT INFORMATION WAS REQUESTED, HOWEVER, NO INFORMATION HAS BEEN RECEIVED. DEVICE HISTORY RECORD REVIEW AND PRODUCT RETURN IS IN PROGRESS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE OPERATIVE REPORT, HOWEVER IT WAS REPORTED THAT THE INFORMATION COULD NOT BE RELEASED. THE REASON FOR EXPLANT REMAINS UNKNOWN. OVERALL, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSIO II ANNULOPLASTY RING EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-10H2243

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R