BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 1892389 · Received November 2, 2010

    Report

    Report Number
    8021545-2010-00011
    Event Type
    Death
    Date Received
    November 2, 2010
    Date of Event
    April 5, 2010
    Report Date
    November 2, 2010
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K002138
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED OR UNUSED DEVICE(S) WERE RETURNED TO UNOMEDICAL A/S THE MFR. AN EVAL OR TESTING OF THE DEVICE(S) WAS NOT CONDUCTED. EVAL SUMMARY: USED DEVICE: NO USED DEVICES WERE RETURNED FOR EVAL. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR EVAL. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE NOT TESTED DUE TO MISSING LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    PT DIED IN A MOTORCYCLE ACCIDENT CAUSED BY ANOTHER MOTORIST LOSING THE CONTROL OF THE VEHICLE. DEATH WAS CAUSED BY A HEAD TRAUMA AND OTHER INJURIES FROM THE ACCIDENT. THE DEATH OF THE PT WAS NOT DIABETES RELATED. PT'S DOCTOR IS (B)(4). WIFE HAS THE PUMP, RESERVOIR AND THE INFUSION SET, THAT THE PT USED AT THE TIME OF DEATH. SHE WILL SEND THE ITEMS BACK FOR ANALYSIS, BUT WOULD LIKE TO HAVE THE PUMP RETURNED SO THAT SHE CAN DONATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PARADIGM FDA FPA UNOMEDICAL A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death