BEUDAMED
    FDA Adverse Event Other Summary report: N

    INCA

    MDR report key: 4340661 · Received December 9, 2014

    Report

    Report Number
    1216677-2014-00018
    Event Type
    Other
    Date Received
    December 9, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 29, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COOPERSURGICAL INC IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. A FINAL REPORT WILL BE FILED AFTER CUSTOMER FOLLOW UP AND INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    HOSPITAL REPORTED INCA PRONGS DISCONNECTING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792699 INCA BZD COOPERSURGICAL, INC. 44-2712 161425

    Patients

    Seq Age Sex Outcome Treatment
    1 Other