BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TICRON 2-0 8 X 30" WHITE/BLUE Y-31 DA PGT

    MDR report key: 343934 · Received July 24, 2001

    Report

    Report Number
    2648188-2001-00023
    Event Type
    Malfunction
    Date Received
    July 24, 2001
    Date of Event
    June 22, 2001
    Report Date
    June 26, 2001
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS COMPAN
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A AORTIC VALVE REPAIR/CABG. REPORTEDLY, THE SUTURE BROKE WHILE TYING. THE SUTURE WAS REPLACED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33271 TICRON 2-0 8 X 30" WHITE/BLUE Y-31 DA PGT BRAIDED POLYESTER SUTURES GAS KENDALL HEALTHCARE PRODUCTS COMPAN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN