BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

    MDR report key: 3121904 · Received May 21, 2013

    Report

    Report Number
    0001811755-2013-01144
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED CUSTOMER CONTACT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS IS A GENERAL PRODUCT COMPLAINT, NOT AGAINST A SPECIFIC UNIT. THE ACCOUNT DID NOT REQUEST SERVICE OF THE UNITS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE SUBMITTED. THIS IS A GENERAL PRODUCT COMPLAINT, NOT AGAINST A SPECIFIC UNIT. THE ACCOUNT DID NOT REQUEST SERVICE OF THE UNITS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVERS AT THE CUSTOMER ACCOUNT ARE VERY LOUD AND HAVE ALLEGEDLY CAUSED HEARING LOSS AND INCREASED STRESS LEVELS OVER THE YEAR. THERE WERE NO REPORTS OF MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVERS AT THE CUSTOMER ACCOUNT ARE VERY LOUD AND HAVE ALLEGEDLY CAUSED HEARING LOSS AND INCREASED STRESS LEVELS OVER THE YEAR. THERE WERE NO REPORTS OF MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVERS AT THE CUSTOMER ACCOUNT ARE VERY LOUD AND HAVE ALLEGEDLY CAUSED HEARING LOSS AND INCREASED STRESS LEVELS OVER THE YEAR. THERE WERE NO REPORTS OF MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224693 NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1