BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3111766 · Received April 17, 2013

    Report

    Report Number
    9617613-2013-00165
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    August 6, 2003
    Report Date
    March 20, 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
    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, INJURY, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165928 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 02A31

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other