BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL PRODUCT

    MDR report key: 2901279 · Received November 8, 2012

    Report

    Report Number
    9617613-2012-00243
    Event Type
    Injury
    Date Received
    November 8, 2012
    Report Date
    October 12, 2012
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    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). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT NUMBER: 411314 FOR AN "UNKNOWN PELVICOL". ADD'L INFO FROM IMPORTER REPORT: (B)(6) 2012. PELVICOL ACELLULAR COLLAGEN MATRIX. (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L INFO FROM IMPORTER REPORT: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL PRODUCT PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC NA 07B09-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AMERICAN MEDICAL SYSTEMS MONARC SUBFASCIAL HAMMOCK