BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7654505 · Received July 2, 2018

    Report

    Report Number
    2210968-2018-73972
    Event Type
    Injury
    Date Received
    July 2, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: JOURNAL OF SURGICAL ONCOLOGY 2010;102:184¿186; DOI 10.1002/JSO.21587. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : THE SUTURE SCAFFOLD TECHNIQUE FOR IMPROVED COSMESIS IN PARTIAL MASTECTOMY DEFECTS". AUTHOR : SARAH M. GAINER, MD,1 EDWARD LEE, MD,2 AND ANTHONY LUCCI, MD, FACS. CITATION: JOURNAL OF SURGICAL ONCOLOGY 2010;102:184¿186; DOI 10.1002/JSO.21587. THE STUDY AIMED TO DESCRIBE A TECHNIQUE FOR PLACEMENT OF PERMANENT SUTURES TO RE-APPROXIMATE TISSUE PILLARS AFTER SEGMENTAL MASTECTOMY. FROM 2007 TO 2009, 215 FEMALE PATIENTS WITH SEGMENTAL MASTECTOMY DEFECTS UNDERWENT CLOSURE USING PERMANENT SUTURE MATERIAL. IN THIS TECHNIQUE, A ¿¿PROLENE SUTURE SCAFFOLD¿¿ IS CREATED BETWEEN THESE PILLARS USING 4-0 PROLENE SUTURES (SURGIPRO V20). THE DEEP DERMIS WAS CLOSED USING BURIED INTERRUPTED 2-0 VICRYL SUTURES. THE EPIDERMIS/DERMIS IS THEN CLOSED USING A RUNNING SUBCUTICULAR 4-0 MONOCRYL SUTURE. POSTOPERATIVELY, 6 PATIENTS DEVELOPED CELLULITIS THAT RESOLVED WITH ORAL ANTIBIOTICS. THIS TECHNIQUE MAY ALSO ALLOW THOSE PATIENTS WHO MIGHT NOT HAVE BEEN GOOD CANDIDATES FOR BREAST CONSERVATION DUE TO SMALL BREAST SIZE AND CONCERNS OF POOR COSMESIS TO UNDERGO BREAST CONSERVATION AND ACHIEVE ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497882 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention