BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1862616 · Received October 8, 2010

    Report

    Report Number
    2015691-2010-14185
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 17, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER LETTER NOT REQUESTED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. METHOD: DEVICE DISCARDED. NO PRODUCT RETURN.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AFTER 14.07 MONTHS DUE TO UNKNOWN REASON. THE 5200M30 WAS IMPLANTED AS A REPLACEMENT. INFORMATION WAS LEARNED THROUGH (B)(6) IMPLANT PATIENT REGISTRY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 07J243

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R