BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 5813202 · Received July 21, 2016

    Report

    Report Number
    9617613-2016-00048
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    December 14, 2004
    Report Date
    June 29, 2016
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, DIFFICULTY INITIATING URINATION, CATHETER RE-INSERTION AND NONSURGICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465474 UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention