BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELHI VALVE # 27

    MDR report key: 1130545 · Received August 22, 2008

    Report

    Report Number
    MW5008049
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 22, 2008
    Manufacturer
    SHELHIGH, INC.
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD TO HAVE ANOTHER VALVE PUT IN BECAUSE THIS VALVE WAS RECALLED. PT WAS ASYMPTOMATIC. CULTURES WERE TAKEN AND NO ORGANISMS WERE SEEN. REPORTER DOES NOT KNOW IF DEVICE WAS SAVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHELHI VALVE # 27 AORTIC VALVE REPLACEMENT LWR SHELHIGH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention