BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1885202 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08420
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BLISTER. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SOME BLISTERS ON HIS HEAD. PATIENT FELT ITCHING UNDER SCALP AND LITTLE EDEMA. THE PATIENT HAD GONE BACK TO HOSPITAL FOR DRESSING WOUNDS ON (B)(6) 2010. IT WAS SUGGESTED PT RETURN TO THE HOSP AGAIN AS SOON AS POSSIBLE. IT WAS LATER REPORTED PT WENT TO HOSPITAL FOR HANDLING. IT WAS NOTED THERE STILL EXISTED AN INFECTION IN THE BACK OF PT'S EAR AND A "MUNG" BEAN SIZE BLISTER. THE PHYSICIAN ADVISED THE PATIENT TO TAKE SOME MEDICINE TO CONTROL THE INFECTION. PATIENT WAS TOLD IF INFECTION CONTINUED TO GET WORSE, PATIENT WILL GO BACK TO HOSPITAL. PATIENT HAD DEVICE EXPLANTED AND REPLACED. IT WAS NOTED LEAD/EXTENSION/ACCESSORY BREAKAGE. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention