BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLIGEN MATRIX

    MDR report key: 3252323 · Received July 23, 2013

    Report

    Report Number
    9617613-2013-00603
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    March 25, 2004
    Report Date
    May 18, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    Additional Manufacturer Narrative · 1

    MEDTRONIC COMPLAINT REPORT: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENTS ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. REASON FOR MESH IMPLANTATION: TYPE 3 STRESS URINARY INCONTINENCE. PROCEDURE (S) PERFORMED: CYSTOSCOPY AND PUBOVAGINAL SLING WITH PELVICOL PATCH 2X12CM UNDER GENERAL ANESTHESIA. COMPLICATIONS: COMPLICATIONS POST PELVICOL PLACEMENT: OUTCOMES ATTRIBUTED TO THE DEVICE INCLUDES ¿PAIN, EROSION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341896 PELVICOL ACELLULAR COLLIGEN MATRIX PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 03B01

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other