BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 3040378 · Received March 25, 2013

    Report

    Report Number
    9617613-2013-00116
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    May 12, 2009
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE RPTR: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121605 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE NA 07B11-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other