BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 1942172 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10013
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELL WHEN GETTING OUT OF THE BATH SOMETIME AROUND THE 27TH OF SEPTEMBER. A FURTHER MORE SERIOUS FALL OCCURRED AROUND THE WEEK OF THE 4TH OCTOBER WHILE PT WAS ON HOLIDAY IN (B)(6). THE SECONDARY FALL RESULTED IN THE PT LANDING ON HER BACK, WHERE THE DEVICE WAS LOCATED. THE PT WAS HAVING INTERMITTENT STIMULATION; THE DEVICE ALSO APPEARED TO TURN ITSELF OFF ON OCCASION. TROUBLESHOOTING, INCLUDING EXPLORATORY SURGERY, WAS PLANNED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37714 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention UNK.