BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 52321 · Received November 26, 1996

    Report

    Report Number
    1627803-1996-00057
    Event Type
    Malfunction
    Date Received
    November 26, 1996
    Date of Event
    November 20, 1996
    Report Date
    November 26, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H6 EVALUATION CODES METHOD CODES: (86) OTHER - DEVICE HISTORY RECORDS REVIEW PERFORMED. RESULT CODES: (100) DEVICE HISTORY RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS FOR A SIZE 21 SUPRA VALVE AT THE TIME OF MFR AND RELEASE.

    Description of Event or Problem · 1

    VALVE WAS INVERTED ON THE HOLDER. EVENT DID NOT ADVERSELY AFFECT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE Implant PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. S500 A275537-F

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO