BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 6 MODULE

    MDR report key: 2842024 · Received November 14, 2012

    Report

    Report Number
    1811755-2012-04090
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE SYSTEM 6 BATTERY MODULE WAS SENT FOR EVALUATION BECAUSE IT WAS TOO DIFFICULT TO REMOVE THE BATTERIES FROM THE CHARGER. WHEN TRYING TO REMOVE THE BATTERY FROM THE MODULE A NURSE HAD TO FORCEFULLY REMOVE THE BATTERY AND AS A RESULT SHE HIT HERSELF IN THE HEAD WITH THE BATTERY AND HAD TO HAVE AN MRI. IT WAS FURTHER REPORTED THAT THERE WERE NO FURTHER ISSUES REPORTED AS A RESULT OF THIS EVENT. THE MRI CAME BACK AND IT WAS REPORTED THAT THE NURSE WAS FINE AND DID NOT HAVE A CORNEAL ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 MODULE KIJ STRYKER INSTRUMENTS KALAMAZOO 11308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNKNOWN BATTERY