BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 5644386 · Received May 10, 2016

    Report

    Report Number
    9617613-2016-00002
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    January 17, 2008
    Report Date
    February 24, 2016
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD'S TRACKING NUMBER: (B)(4). H11: CORRECTED DATA - D4 LOT #; SERIAL # NOT AVAILABLE AS INITIALLY REPORTED.

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD'S TRACKING NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). (B)(4).

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD'S TRACKING NUMBER: (B)(4). H11: CORRECTED DATE - D4 MODEL # AND CATALOG #

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD'S TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT ALLEGED EXPERIENCING AN UNSPECIFIED ADVERSE EVENT AS A RESULT OF THE DEVICE IMPLANTATION.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, RECURRENT STRESS/URGE URINARY INCONTINENCE, GRADE 2 CYSTOCELE, PERINEAL LAXITY, PAIN, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298193 PELVICOL 2CM X 7CM 1.0MM MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR 482812 07B03-8

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention