BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-SLING

    MDR report key: 4275322 · Received October 30, 2014

    Report

    Report Number
    4275322
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    July 22, 2014
    Report Date
    October 30, 2014
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    PAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    OSTEITIS PUBIS VERSUS MESH-RELATED PAIN AFTER MID-URETHRAL SLING. PATIENT REPORTS THAT SHE HAS BEEN HAVING SUPRAPUBIC PAIN SINCE THE TIME OF HER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694709 T-SLING MESH, SURGICAL, GYNECOLOGIC PAH COLOPLAST MANUFACTURING US, LLC * 3218509

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR