BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLAR COLLAGEN MATRIX 4X7CM

    MDR report key: 3131362 · Received May 20, 2013

    Report

    Report Number
    9617613-2013-00271
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 15, 2002
    Report Date
    August 18, 2023
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    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 TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222982 PELVICOL ACELLAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL TISSUE SCIENCE LABORATORIES, PLC 01A20

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other