BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2190927 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-05886
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD REDNESS BEHIND HIS EARS AND ON THE FRONT OF HIS CHEST, AS WELL AS "FLUID." THE SKIN ON THE PT'S CHEST HAD DARKENED. NO RUPTURES WERE LOCATED. THE PHYSICIAN SUSPECTED INFECTION OR DEVICE REJECTION. AN INFECTION HAD NOT YET BEEN CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED ON AN UNK DATE. THE PT HAD BEEN DISCHARGED.

    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 57 YR Required Intervention