BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IVS TUNNELLER DEVICE

    MDR report key: 2896034 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01032
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    November 26, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IVS TUNNELLER DEVICE IVS TUNNELLER FTL COVIDIEN LP, FORMERLY US SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other