BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 2436854 · Received January 27, 2012

    Report

    Report Number
    3003442380-2012-00002
    Event Type
    Death
    Date Received
    January 27, 2012
    Date of Event
    December 20, 2011
    Report Date
    January 27, 2012
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S HAS UNFORTUNATELY NOT RECEIVED ANY USED OR UNUSED DEVICES. THE FACT THAT THE LOT NUMBER IS UNK PREVENT US FROM HAVING THE RETAINED SAMPLES FROM THE RESERVE LOT TESTED. SHOULD WE BECOME AWARE OF ANY RELEVANT INFO OR SHOULD THE ACTUAL DEVICE IN THE INCIDENT BE RETURNED TO US WE WILL RE-OPEN THE CASE AND THE TEST RESULT OR THE RELEVANT INFO WILL BE SUBMITTED IN A FOLLOW UP REPORT. WE CONSIDER THE CASE FOR CLOSED.

    Description of Event or Problem · 1

    REPORTER'S NAME: (B)(6). PHONE NUMBER OF CALLER: (B)(6). NAME OF THE DECEASED: (B)(6). CAUSE OF DEATH: UNKNOWN. LOCATION OF DEATH: HOME, (B)(6). TIME OF DEATH: (B)(6) 2011, MD'S NAME SND CONTACT INFO: UNKNOWN. REPORTER STATED DECEASED PARTY WAS WEARING THE PUMP AT THE TIME OF DEATH. CONTACT INFO OF OTHER PARTIES INVOLVED OR KNOWLEDGEABLE ABOUT DEATH EVENT: (B)(4). PATIENT BG AT TIME OF DEATH OR LAST RECORDED WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death