BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 2255129 · Received September 12, 2011

    Report

    Report Number
    8021545-2011-00009
    Event Type
    Death
    Date Received
    September 12, 2011
    Date of Event
    July 26, 2011
    Report Date
    September 9, 2011
    Product Code
    FPA
    PMA / PMN Number
    K002138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO USED OR UNUSED DEVICES WERE RETURNED TO UNOMEDICAL A/S. NO LOT NUMBER WAS AVAILABLE WHICH PREVENTED US FROM HAVING THE RETAINED SAMPLES TESTED. WE CONSIDER THIS CASE AS CLOSED, HOWEVER, INFO REGARDING THE LOT NUMBER OR RECEIVING THE INVOLVED DEVICE WOULD HAVE US TO REOPENED THE CASE AND NEW REPORT WILL BE SUBMITTED. EVALUATION SUMMARY, MFR REPORT # (B)(4): USED DEVICE: NO USED DEVICES WERE RETURNED FOR TESTING. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR TESTING. REFERENCE SAMPLES: NO RETAINED SAMPLES WERE TESTED DUE TO LOT NUMBER BEING UNKNOWN.

    Description of Event or Problem · 1

    CALLER (B)(6) (WIFE) CALLED TO REPORT THE DEATH OF (B)(6). DATE OF THE DEATH WAS (B)(6) 2011 CALLER STATED THE CAUSE OF DEATH WAS HEART ATTACK. (B)(6) STATED (B)(6) PASSED AWAY IN THE HOSPITAL. DOCTOR'S NAME IS DR. (B)(6) CONTACT INFO IS (B)(6). (B)(6) STATED THAT (B)(6) WAS WEARING HIS PUMP AT THE TIME OF DEATH. CALLER STATED THAT (B)(6) HAD A HEART ATTACK ON (B)(6) 2011 AROUND 8 AM AND HE PASSED AWAY ON (B)(6) 2011 AROUND 2 AM. (B)(6) STATED DOES NOT HAVE ANY OTHER DETAILS. STATED THE ONLY PARTIES THAT ARE INVOLVED OR DIRECTLY KNOWLEDGEABLE ABOUT THE INCIDENT AND AWARE OF THE DEATH IS FAMILY MEMBERS AND THE EMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PARADIGM INFUSION SET FPA MMT-378 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death