BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1953522 · Received January 5, 2011

    Report

    Report Number
    3004209178-2011-00097
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 7, 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).

    Description of Event or Problem · 1

    THE DEVICE WAS TURNED ON THE PREVIOUS FRIDAY. THE PT FELT MUSCLE PAIN AND STIFFNESS UPPER AND LOWER EXTREMITIES ON THE FOLLOWING MONDAY NIGHT. THE DEVICE WAS REPLACED. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention