BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLIGEN MATRIX

    MDR report key: 2901194 · Received November 7, 2012

    Report

    Report Number
    9617613-2012-00237
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    COVIDIENT, FORMERLY TISSUE SCIENCE
    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). (B)(6), DATE OF REPORT: (B)(4) 2012, DEVICE MFR: TISSUE SCIENCE LABS, (B)(4). (B)(6).

    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. IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL ACELLULAR COLLIGEN MATRIX PELVICOL MESH FTL COVIDIENT, FORMERLY TISSUE SCIENCE NA 04508-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R