BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2488612 · Received March 12, 2012

    Report

    Report Number
    3005075853-2012-01074
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    December 1, 2010
    Report Date
    February 29, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LKF
    PMA / PMN Number
    K940681
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BALLOON WAS PERFORATED. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE MANIPULATOR - 7CM LKF ETHICON ENDO-SURGERY, LLC. NA G4TL89

    Patients

    Seq Age Sex Outcome Treatment
    1