BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 3220935 · Received July 3, 2013

    Report

    Report Number
    9617613-2013-00450
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    October 18, 2002
    Report Date
    June 10, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: STRESS UI / PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306596 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 01A25

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other URETEX SUPPORT PP KIT X1, URETEXSUP, LOT #22200SUP| EXP: 07/31/2007, MFR: 07/2002