BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL PRODUCT

    MDR report key: 2840391 · Received August 1, 2012

    Report

    Report Number
    9617613-2012-00091
    Event Type
    Injury
    Date Received
    August 1, 2012
    Date of Event
    April 6, 2004
    Report Date
    July 16, 2012
    Manufacturer
    COVIDIENT, 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).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL PRODUCT PELVICOL MESH FTL COVIDIENT, FORMERLY TISSUE¿ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R