BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 10826340 · Received November 11, 2020

    Report

    Report Number
    2210968-2020-08980
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    February 1, 2019
    Report Date
    October 29, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT : (B)(4). 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 REGARDING THE ADDITIONAL EVENTS CITATION: MED FORUM 2019;30(2):PAGES 6-9; DOI: NOT REPORTED. EVENTS WERE SUBMITTED VIA 2210968-2020-08979.

    Description of Event or Problem · 1

    TITLE: 'POSTOPERATIVE WOUND CLOSURE AND COSMETIC OUTCOMES OF SUTURES AND STAPLERS IN THYROID SURGERY AT TERTIARY CARE HOSPITAL'. THIS COMPARATIVE STUDY AIMS TO DETECT THE BEST MATERIAL USED IN ORDER TO GET LEAST POSTOPERATIVE COMPLICATIONS AND GOOD COSMETIC RESULTS FOR RESTORING THE NORMAL ANATOMY OF AFFECTED ORGAN. FROM DECEMBER 2016 TO NOVEMBER 2018, 45 PATIENTS UNDERWENT THYROIDECTOMY, AND WERE INCLUDED IN THIS STUDY. AFTER THYROIDECTOMY, SKIN CLOSURE WAS DONE BY PROLENE#0 (ETHICON) (N=7), PROLENE#1 (ETHICON) (N=7) AND PROLENE 2/0 (ETHICON) (N=6), MERSILK#1 (ETHICON) (N=15), AND ALSO THE STAPLERS (N=20). POSTOPERATIVELY, WOUND INFECTION (N=1) AND STITCH GRANULOMA (N=2) WERE REPORTED FOR THE USE OF PROLENE #0, #1 AND #2/0 (ETHICON) SUTURES. AND FOR THE MERSILK #1 (ETHICON) SUTURE, WOUND INFECTION (N=4), WOUND DEHISCENCE (N=1) AND ABSCESS FORMATION (N=1) WERE REPORTED. THIS STUDY CONCLUDED THE INCREASED INFLAMMATION OF WOUND AND INCREASE PAIN IN WOUND AFTER USE OF POLYGLACTIN AND POLYPROPYLENE RESPECTIVELY AND NO INCREASED PAIN IN WOUND WAS NOTED AFTER USE OF POLYPROPYLENE. OUR STUDY CONCLUDED THAT POLYPROPYLENE IS THE BEST SUTURE WITH LEAST POSTOPERATIVE COMPLICATIONS, AND EXCELLENT COSMETIC RESULT IN THYROID SURGERIES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290278 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1