BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7760142 · Received August 7, 2018

    Report

    Report Number
    2210968-2018-74992
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    July 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY & VOLUME 17, NUMBER 5, SUPPLEMENT 2, SEPTEMBER/OCTOBER 2011 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : RISK FACTORS FOR VAGINAL MESH EXPOSURE AFTER ROBOTIC-ASSISTED LAPAROSCOPIC SACROCOLPOPEXY: A RETROSPECTIVE COHORT STUDY" AUTHOR: D. EL-KHAWAND, S. A. WEHBE, D. ARUNACHALAM, E. SAKS, H. GOLDSTEIN, K. WHITMORE, B. VAKILI CITATION: FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY & VOLUME 17, NUMBER 5, SUPPLEMENT 2, SEPTEMBER/OCTOBER 2011 THE PURPOSE OF THIS RETROSPECTIVE COHORT STUDY WAS TO IDENTIFY RISK FACTORS FOR VAGINAL MESH EXPOSURE AFTER ROBOTIC-ASSISTED LAPAROSCOPIC SACROCOLPOPEXY (RSC). BETWEEN JAN2009 AND DEC2010, 93 FEMALE PATIENTS UNDERWENT RSC. IN THE PROCEDURE, ETHIBOND OR PROLENE SUTURES WERE USED TO FIX THE MESH. IN THE MEAN FOLLOW-UP OF 20 WEEKS (SD±15 WEEKS), EXPOSURE WAS NOTED IN 16 PATIENTS COMPRISING OF MESH EXPOSURE (N=15) AND SUTURE EXPOSURE (N=1). TWELVE OF THESE EXPOSURES UNDERWENT SURGICAL THERAPY AFTER FAILED MEDICAL TREATMENT. IN THESE CASES, 30% UTILIZED ETHIBOND SUTURES AND 9.8% UTILIZED PROLENE SUTURES. ALTHOUGH NO DEFINITIVE RISK FACTORS WERE IDENTIFIED ON MULTIVARIATE ANALYSIS, INCIDENTAL ANTERIOR VAGINOTOMY, EARLY LEARNING CURVE, CAUTERY USE, AND SUTURE MATERIAL MAY BE ASSOCIATED WITH HIGHER VAGINAL MESH EXPOSURE RATES AFTER RSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598385 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention