BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STL MF K-61 1N 30"X2

    MDR report key: 382910 · Received March 19, 2002

    Report

    Report Number
    1221601-2002-00002
    Event Type
    Injury
    Date Received
    March 19, 2002
    Report Date
    March 18, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GE
    Product Code
    GAQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THE STEEL SUTURE NEEDLE BROKE IN HALF WHILE TRYING TO CLOSE THE STERNUM. THE CUSTOMER USED X-RAY TO RECOVER THE BROKEN PARTS. THERE WAS NO INJURY TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STL MF K-61 1N 30"X2 STAINLESS STEEL SUTURE GAQ GENZYME BIOSURGERY A DIVISION OF GE E2-5367M2 391482

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention