BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 6095320 · Received November 11, 2016

    Report

    Report Number
    9614846-2016-00194
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 23, 2012
    Report Date
    November 10, 2016
    Manufacturer
    HERNIAMESH SRL
    Product Code
    PAH
    UDI-DI
    28032919892120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    PLAINTIFF IMPLANTED WITH T-SLING 5194001400 ON (B)(6) 2010. MESH REMOVAL OCCURRED ON (B)(6) 2012. PATIENT'S LEGAL REPRESENTATIVE STATED URINARY RETENTION; LLQ PAIN; MESH RESTRICTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748634 T-SLING URINARY INCONTINENCE SLING PAH HERNIAMESH SRL 5194001400 0637 28032919892120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S