BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 6114311 · Received November 18, 2016

    Report

    Report Number
    9617613-2016-00096
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    April 12, 2005
    Report Date
    October 21, 2016
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER). C.R. BARD REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, EROSION AND URINARY INCONTINENCE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PATIENT HAS EXPERIENCED INJURY, PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA, ADDITIONAL SURGERIES, EROSION AND URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT, URINARY PROBLEMS, AND DYSPAREUNIA. PATIENT HAS REQUIRED ADDITIONAL SURGICAL INTERVENTIONS. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765877 UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other