BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE SURGICAL LIGATURE

    MDR report key: 6145073 · Received December 1, 2016

    Report

    Report Number
    MW5066517
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ETHICON, INC.
    Product Code
    HDH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING CERCLAGE, NEEDLE BROKE OFF OF SUTURE INTO VAGINAL WALL. SURGEONS WERE UNABLE TO RETRIEVE IT DESPITE ULTRASONOGRAPHY ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791022 MERSILENE SURGICAL LIGATURE MERSILENE SURGICAL LIGATURE HDH ETHICON, INC. RS23/P30

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention