BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8258628 · Received January 17, 2019

    Report

    Report Number
    2210968-2019-78476
    Event Type
    Injury
    Date Received
    January 17, 2019
    Report Date
    January 4, 2019
    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: INT UROGYNECOL J (2006) 17: 621¿623; DOI 10.1007/S00192-006-0079-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CYSTOCELE¿VAGINAL APPROACH TO REPAIRING PARAVAGINAL FASCIAL DEFECTS." AUTHOR(S): RUI VIANA, JOÃO COLAÇO, ÁGUEDA VIEIRA, VITOR GONÇALVES, HÉLIO RETTO. CITATION: INT UROGYNECOL J (2006) 17: 621¿623; DOI 10.1007/S00192-006-0079-9. THIS STUDY WAS DESIGNED WITH THE OBJECTIVE OF DETERMINING THE SAFETY AND EFFICACY OF A VAGINAL APPROACH FOR REPAIR OF PARAVAGINAL FASCIAL DEFECTS IN PATIENTS WITH SYMPTOMATIC CYSTOCELES. BETWEEN JAN2002 AND MAR2005, 66 FEMALE PATIENTS (MEAN AGE OF 65.8 YEARS [RANGED 45-79 YEARS]) WITH GRADE 2 TO 4 SYMPTOMATIC CYSTOCELE UNDERWENT SURGICAL REPAIR THROUGH A VAGINAL APPROACH. IN THE PROCEDURE, TWO TO FOUR ETHIBOND SUTURES WERE PLACED IN THE ARCUS TENDINOUS, DEPENDING ON THE SIZE OF THE DEFECT. AFTER PLACEMENT OF ALL LATERAL PELVIC SIDEWALL SUTURES ON ONE OR BOTH SIDES, THE SUTURES WERE ATTACHED TO THE ENDOPELVIC FASCIA. THE ANTERIOR VAGINAL MUCOSA WAS CLOSED WITH A CONTINUOUS VICRYL 2-0 SUTURE. INTRAOPERATIVE COMPLICATIONS INCLUDED MINOR INTRAOPERATIVE HEMORRHAGE (N=25) WHICH DID NOT REQUIRE TRANSFUSION OF BLOOD OR DERIVATIVES. DURING IN-PATIENT STAY, COMPLICATIONS INCLUDED URINARY RETENTION (N=4) WHICH WERE MEDICALLY TREATED; LOWER URINARY TRACT INFECTION (N=3) TREATED WITH OUTPATIENT ANTIBIOTICS; AND VAGINAL HEMATOMA (N=1) WHICH REQUIRED 10 DAYS OF HOSPITAL STAY FOR CLINICAL SURVEILLANCE. AT 6 MONTHS FOLLOW-UP, COMPLICATIONS INCLUDED URINARY URGENCY (N=2), DE NOVO URINARY INCONTINENCE (N=2), AND RECURRENCE OF CYSTOCELE GRADE 2 (N=4) AND GRADE 3 (N=1) WHICH MAINTAINED AT 12 MONTHS FOLLOW-UP. AT 12 MONTHS FOLLOW-UP, TWO PATIENT COMPLAINED OF DYSPAREUNIA WHICH PROGRESSIVELY IMPROVED IN THE LAST 3 MONTHS. FAILURE WITH GRADE 3 AND 4 CYSTOCELE WAS REPORTED IN ONE PATIENT AT 12-MONTH FOLLOW-UP. SURGICAL REPAIR OF SYMPTOMATIC CYSTOCELE THROUGH A PARAVAGINAL APPROACH IS A SAFE AND EFFICACIOUS TECHNIQUE. VAGINAL APPROACH TO REPAIR PARAVAGINAL FASCIA DEFECTS HAD A LOW POSTOPERATIVE MORBIDITY AND HIGH CURE RATE AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51239 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention