BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 2901276 · Received December 4, 2012

    Report

    Report Number
    9617613-2012-00265
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 7, 2012
    Manufacturer
    COVIDIEN FORMERLY 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO REPORTER: PER ADDITIONAL INFO RECEIVED, THE PATIENT HAS EXPERIENCED FREQUENT URINARY TRACT INFECTIONS, CONTINUED STRESS INCONTINENCE, RECURRENT CYSTOCELE, PAIN, AND MESH EROSION. ADD'L INFO FROM IMPORTER REPORT: IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THAT PRODUCT IMPLANTED, THE PT HAS EXPERIENCED FREQUENT URINARY TRACT INFECTIONS, CONTINUED STRESS INCONTINENCE, RECURRENT CYSTOCELE, PAIN, AND MESH EROSION. ASSOCIATED MDR #: 1018233-2012-00489.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PELVICOL PRODUCT PELVICOL MESH FTL COVIDIEN FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other URETEX URETHRAL SUPPOR SYSTEM