BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 3736829 · Received April 9, 2014

    Report

    Report Number
    2210968-2014-04611
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A NORWOOD OPERATION OPEN HEART PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. THE PATIENT DEVELOPED A WOUND INFECTION. WITHIN TWO WEEKS, THERE WAS STERNAL WOUND BREAKDOWN THAT REQUIRED TREATMENT WHERE THEY OPENED, PACKED, AND DEBRIDED THE WOUND. THE PATIENT RECEIVED A WOUND VAC AS PART OF TREATMENT AND THE STEEL SUTURES WERE REMOVED. THE PATIENT WAS TREATED WITH A COURSE OF ANTIBIOTICS. THE SURGEON OPINES THAT NUTRITION,HYPOXIA AND PREVIOUS INFECTIONS ARE ALL WERE CONTRIBUTING FACTORS TO THE WOUND INFECTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A NORWOOD OPERATION OPEN HEART PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. THE PATIENT DEVELOPED A WOUND INFECTION. WITHIN TWO WEEKS, THERE WAS STERNAL WOUND BREAKDOWN THAT REQUIRED TREATMENT WHERE THEY OPENED AND PACKED THE WOUND. THE PATIENT RECEIVED A WOUND VAC AS PART OF TREATMENT AND THE STEEL SUTURES WERE REMOVED. THE SURGEON IS CONCERNED FOR AN ALLERGY TO THE PRODUCT, SPECIFICALLY NICKEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214629 SURGICAL STAINLESS STEEL SUTURE SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention