BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7870803 · Received September 12, 2018

    Report

    Report Number
    2210968-2018-75810
    Event Type
    Injury
    Date Received
    September 12, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. CITATION: GUT. 2015 JUN; CONFERENCE: 2ND DIGESTIVE DISORDERS FEDERATION CONFERENCE, DDF 2015. LONDON UNITED KINGDOM. CONFERENCE PUBLICATION: (VAR.PAGINGS). 64 (SUPPL. 1):A378 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SAFETY AND EFFICACY OF LAPAROSCOPIC VENTRAL MESH RECTOPEXY AND SACROCOLPOPEXY FOR RECTAL PROLAPSE AND OBSTRUCTED DEFECATION: ANALYSIS OF FIRST 20 CASES AT A UK DISTRICT GENERAL HOSPITAL" AUTHOR(S): TENNAKOON A., FAROOK G. CITATION: GUT. 2015 JUN; CONFERENCE: 2ND DIGESTIVE DISORDERS FEDERATION CONFERENCE, DDF 2015. LONDON UNITED KINGDOM. CONFERENCE PUBLICATION: (VAR.PAGINGS). 64 (SUPPL. 1):A378 THE AIM OF THIS STUDY WAS TO PRESENT THAT LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR) CAN BE LEARNT AND SAFELY PERFORMED WITH SHORT TERM RESULTS SIMILAR TO THAT OF ESTABLISH CENTRES. FROM JANUARY 2011 TO JANUARY 2015, 20 PATIENTS WITH OBSTRUCTED DEFECATION (ODS) AND RECTAL PROLAPSE UNDERWENT LVMR. IN THE PROCEDURE, ETHIBOND EXCEL 2/0 SUTURE WAS USED TO ATTACH THE MESH TO THE RECTUM AND VICRYL 2/0 WAS USED FOR COLPOPEXY. COLPOPEXY WAS PERFORMED IN 90% OF THE PATIENTS WITH ZERO 30-DAY MORTALITY. COMPLICATIONS INCLUDED WOUND INFECTION (N=1), RECURRENCE OF ODS AFTER ONE YEARS (N=1), AND RECURRENT PROLAPSE WITH ANTERIOR AND POSTERIOR VAGINAL PROLAPSE AFTER 6 MONTHS (N=1). THE AUTHORS SUGGEST THAT EXPERIENCED LAPAROSCOPIC SURGEONS CAN LEARN AND SAFELY PERFORM LAPAROSCOPIC VENTRAL MESH RECTOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711428 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention