BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCR 2/0 W-B 8X30 Y-31 D/A 3X7 FIRM PGT

    MDR report key: 2062387 · Received April 6, 2011

    Report

    Report Number
    9612501-2011-00023
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    DAVIS AND GECK CARIBE, LTD.
    Product Code
    GAT
    PMA / PMN Number
    K930591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: VALVE REPLACEMENT. ACCORDING TO THE REPORTER: SEVERAL STRANDS OF THE SUTURE BROKE WHILE TYING DOWN ON THE BACK SIDE OF THE VALVE. SURGEON HAD TO START OVER AND IT ADDED OVER AN HOUR TO THE CASE. SWITCHED TO ANOTHER SUTURE TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCR 2/0 W-B 8X30 Y-31 D/A 3X7 FIRM PGT NONABSORBABLE SUTURE PRODUCT GAT DAVIS AND GECK CARIBE, LTD. D0L0524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other