BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL PRODUCT

    MDR report key: 2840370 · Received September 13, 2012

    Report

    Report Number
    9617613-2012-00179
    Event Type
    Injury
    Date Received
    September 13, 2012
    Report Date
    August 14, 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 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 SEVERE MENTAL AND PHYSICAL PAIN AND SUFFERING, DISABILITY, IMPAIRMENT, SERIOUS BODILY INJURIES, MESH EROSION, HARDENING, EROSION OF INTERNAL BODILY TISSUE, WORSENING DYSPAREUNIA, AND RECURRENT INCONTINENCE, WILL REQUIRE ADDITIONAL SURGERIES AND MEDICAL TREATMENTS AND HAS SUSTAINED PERMANENT INJURY.

    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 Female Required Intervention| O