BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 2007512 · Received February 22, 2011

    Report

    Report Number
    8021545-2011-00007
    Event Type
    Death
    Date Received
    February 22, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K002138
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED OR UNUSED DEVICES WERE RETURNED. SISTER OF PATIENT STATED THAT SHE WILL RETURN THE DEVICE WORN BY THE PATIENT AT THE TIME OF DEATH. UNOMEDICAL A/S WILL IF AND WHEN WE RECEIVE THE WORN DEVICE OR THE LOT NUMBER MAKE THE APPROPRIATE TESTING AND EVALUATION. A FOLLOW UP REPORT WILL BE WITHIN 20 DAYS. (B)(4).

    Description of Event or Problem · 1

    SISTER OF THE CUSTOMER CALLED TO REPORT DEATH OF PATIENT. WILL BE RETURNING PUMP, RESERVOIR AND INFUSION SET WORN AT THE TIME OF DEATH. THE ABOVE MENTIONED INFORMATION IS THE INFORMATION AVAILABLE AT THIS POINT. WE WILL TRY TO GET MORE INFORMATION THROUGH OUR DISTRIBUTOR (B)(4). DUE TO NO RETURNED DEVICES AT ALL, NO TESTING COULD BE PERFORMED AND SINCE THE LOT NUMBER IS UNKNOWN, NO TESTING OF THE RETAINED SAMPLE COULD BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PARADIGM FPA UNOMEDICAL A/S MMT-378 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death