BEUDAMED
    FDA Adverse Event Other Summary report: N

    2-0 TUCNOW 3303-56

    MDR report key: 277957 · Received May 16, 2000

    Report

    Report Number
    277957
    Event Type
    Other
    Date Received
    May 16, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 12, 2000
    Manufacturer
    US SURGICAL
    Product Code
    DTH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AORTIC VALVE REPLACEMENT, VALVE SUTURE BROKE: SURGEON LOOKED WITH SCOPE TO MAKE SURE PLEDGET WAS INTACT. NO PLEDGET WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-0 TUCNOW 3303-56 VALVE SUTURE AND PLEDGET DTH US SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other