BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 2163094 · Received July 15, 2011

    Report

    Report Number
    2210968-2011-00905
    Event Type
    Injury
    Date Received
    July 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF SIX MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2011-00903, 2210968-2011-00904, 2210968-2011-00902, 2210968-2011-00906, 2210968-2011-00907. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAPH PROCEDURE AND SUTURE WAS USED FOR CLOSURE OF THE STERNAL HALVES. THE PATIENT EXPERIENCED A STERNAL WOUND DEHISCENCE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE WIRE SUTURES CUT THROUGH THE STERNUM OR THE PLATES FAILED TO HOLD OR BOTH. THE PATIENT UNDERWENT A SURGICAL REAPPROXIMATION OF THE STERNAL HALVES ON AN UNKNOWN DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention