BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 6 X 8 CM

    MDR report key: 3131324 · Received May 17, 2013

    Report

    Report Number
    9617613-2013-00264
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    November 3, 2004
    Report Date
    April 23, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. GYNECARE TVT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219948 PELVICOL 6 X 8 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 04B14-1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other