BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO 8/0 18 BLUE MV-175-8 D/A

    MDR report key: 2210039 · Received August 3, 2011

    Report

    Report Number
    1219930-2011-00620
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAW
    PMA / PMN Number
    K954808
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CORONARY BYPASS. ACCORDING TO THE RPTR: DURING VASCULAR ANASTOMOSIS, 3 SUTURES BROKE IN A ROW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING OCCURRED. THERE WAS NO PT HARM. NOTHING FELL INTO CAVITY. OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 8/0 18 BLUE MV-175-8 D/A NON ABSORBABLE SUTURE PRODUCT GAW UNITED STATES SURGICAL A0A0816V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other