BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1982268 · Received January 25, 2011

    Report

    Report Number
    2210968-2011-00079
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A CORONARY ARTERY BYPASS GRAPH PROCEDURE ON (B)(6)2010 AND SURGICAL STEEL WIRE WAS USED TO CLOSE THE STERNUM. ON (B)(6) 2010, THE PT COMPLAINED OF CHEST PAIN BUT WAS SUBSEQUENTLY SENT HOME. ON (B)(6) 2010, THE PT'S WOUND BECAME REDDISH, WITH PUS OOZING OUT. THE DEEP STERNAL WOUND WAS INFECTED WITH MYCOBACTERIUM FORTUITUM STRAIN. THE INITIAL STERNAL WIRES THAT WERE IMPLANTED WERE REMOVED ON (B)(6) 2010 AND A RECTUS FLAP CLOSURE WAS DONE ON (B)(6) 2010. THE PT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention