BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 6215226 · Received December 30, 2016

    Report

    Report Number
    9614846-2016-00234
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    August 23, 2016
    Report Date
    December 29, 2016
    Manufacturer
    HERNIAMESH SRL
    Product Code
    PAH
    UDI-DI
    28032919892120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL REPRESENTATIVE STATED EXPOSED POSTERIOR PROLAPSE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866245 T-SLING URINARY INCONTINENCE SLING PAH HERNIAMESH SRL 5194001400 28032919892120

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| H| R| S