BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELIVCOL PRODUCT

    MDR report key: 2840315 · Received October 19, 2012

    Report

    Report Number
    9617613-2012-00229
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 9, 2006
    Report Date
    September 20, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (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. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| O