BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 12602494 · Received October 9, 2021

    Report

    Report Number
    2210968-2021-09449
    Event Type
    Injury
    Date Received
    October 9, 2021
    Date of Event
    February 2, 2020
    Report Date
    October 8, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE NOT RETURNED. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE AND ETHILON SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (HEMATOMA, SEROMA, AND WOUND DEHISCENCES) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE AND ETHILON SUTURE) USED IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (HEMATOMA, SEROMA AND WOUND DEHISCENCES)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: INT WOUND J. 2020;17:683¿691. DOI: 10.1111/IWJ.13324. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-09448.

    Description of Event or Problem · 0

    TITLE: DEEP STERNAL WOUND INFECTION FOLLOWING CARDIAC SURGERY: A COMPARISON OF THE MONOLATERAL WITH THE BILATERAL PECTORALIS MAJOR FLAPS FROM (B)(6) 2014 TO (B)(6 2018, A SINGLE-CENTRE RETROSPECTIVE STUDY WAS PERFORMED AND 167 PATIENTS WITH POSTSTERNOTOMY DSWI FOLLOWING CARDIAC SURGERY. ALL PATIENTS WERE TREATED WITH A MULTISTEP PROTOCOL. THE FIRST STEP WAS THE PREOPERATIVE VAC-THERAPY, PERFORMED IN ALL 167 PATIENTS. THE SECOND STEP WAS SURGERY AND TWO STUDY GROUPS WERE CREATED: PATIENTS IN GROUP A WERE TREATED WITH MPMF, WHEREAS PATIENTS IN GROUP B WERE TREATED WITH BPMF. AT THE SUBSEQUENT SURGICAL TIME THE MPMF (GROUP A) WAS RAISED AS THE STANDARD PROCEDURE. THE MUSCLE MONOLATERAL FLAP WAS PLACED UPON THE STERNAL DEFECT AND FIXATED WITHOUT TENSION. CLOSURE WAS PERFORMED IN A MULTILAYER TECHNIQUE USING 2-0 AND 3-0 ABSORBABLE SINGLE STITCHES SUTURES (VICRYL®, ETHICON, (B)(6) FOR THE SUBCUTANEOUS TISSUE AND SAME CALIBRES NON-ABSORBABLE (ETHILON®, ETHICON, (B)(6) SINGLE VERTICAL MATTRESS SUTURES FOR THE SKIN. REPORTED COMPLICATIONS INCLUDED HEMATOMA (N=1), SEROMA (N=6), DEISHENCES (N=7) ,WOUND DEISHENCES (N=8) AND WOUND REVISION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500261 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention