BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-SLING

    MDR report key: 4289458 · Received November 7, 2014

    Report

    Report Number
    4289458
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    July 22, 2014
    Report Date
    November 7, 2014
    Manufacturer
    COLOPLAST CORP.
    Product Code
    PAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECENTLY UNDERWENT A SYNTHETIC MIDURETHRAL SLING. SHE HAS DONE WELL POSTOPERATIVELY; HOWEVER, RECENTLY WAS FOUND TO HAVE A SMALL EXPOSURE OF THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720912 T-SLING MESH, SURGICAL, GYNECOLOGIC PAH COLOPLAST CORP. * 0582

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR