BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 6036430 · Received October 18, 2016

    Report

    Report Number
    9617613-2016-00067
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    October 7, 2002
    Report Date
    October 19, 2017
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: A1, B7, H11 - C.R. BARD REFERENCE NUMBER CORRECTION. EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER). C.R. BARD REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688215 UNKNOWN PELVICOL PRODUCT SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY OTN COVIDIEN, FORMERLY TISSUE SCIENCE LABOR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention