BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT MESH

    MDR report key: 3111799 · Received April 26, 2013

    Report

    Report Number
    9617613-2013-00196
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    December 8, 2004
    Report Date
    April 30, 2018
    Manufacturer
    BARD
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY, AND IMPAIRMENT. DEVICE WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182591 PELVISOFT MESH NONE FTL BARD 481068 04B10-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other