BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY

    MDR report key: 2070828 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01291
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER TESTED THE BATTERY WITH ANOTHER HANDPIECE AND THE BATTERY DID NOT HEAT UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS GETTING HOT. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY GET KIJ STRYKER INSTRUMENTS KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK