BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 13196590 · Received January 7, 2022

    Report

    Report Number
    1219930-2022-00120
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    June 8, 2021
    Report Date
    January 7, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: COMPARISON OF SURGICAL RESULTS AND POSTOPERATIVE RECURRENCE RATES BY LAPAROSCOPIC SACROCOLPOPEXY WITH OTHER SURGICAL PROCEDURES FOR MANAGING PELVIC ORGAN PROLAPSE SOURCE: GYNECOLOGY AND MINIMALLY INVASIVE THERAPY 10 (2021) 221-225. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED OUTCOMES OF PATIENTS WHO UNDERWENT SURGERY FOR PELVIC ORGAN PROLAPSE (POP) BETWEEN 2006 TO 2019. 138 PATIENTS RECEIVED A LAPAROSCOPIC SACROCOLPOPEXY (LSC) WHERE THE POSTERIOR COLPORRHAPHY WAS PERFORMED USING A THE SUTURE. COMPLICATIONS INCLUDED ONE RECTAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170721 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other