BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 42956 · Received October 18, 1996

    Report

    Report Number
    1627803-1996-00053
    Event Type
    Injury
    Date Received
    October 18, 1996
    Date of Event
    September 16, 1996
    Report Date
    October 18, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F10. EVENT PROBLEM CODES BASED ON MFR'S UNDERSTANDING OF EVENT. SECTION H6. METHOD CODE 86: OTHER - DEVICE HISTORY REVIEW AND MICROSCOPY PERFORMED. RESULT CODE 300: OTHER - MFG RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE. CONCLUSION CODE 68: OTHER - PATIENT RELATED FACTORS CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    A PT EXPERIENCED A THROMBOEMBOLIC EVENT LEADING TO REOPERATION AND EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE Implant PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. 700 A138385-D

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R NO INFO RELEASED FROM HOSP