BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION SET

    MDR report key: 2312350 · Received October 27, 2011

    Report

    Report Number
    3003442380-2011-00020
    Event Type
    Death
    Date Received
    October 27, 2011
    Date of Event
    April 18, 2009
    Report Date
    September 28, 2011
    Manufacturer
    UNOMEDICAL DEVICE S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO USED OR UNUSED DEVICES WERE RETURNED TO UNOMEDICAL A/S. DUE TO THE FACT THAT NO LOT NUMBER WAS AVAILABLE THE RETAINED SAMPLES FROM THE RESERVE LOT COULD NOT BE TESTED. IF WE RECEIVE THE USED DEVICE WE WILL TEST AND EVALUATE AND IF THE RESULT REQUIRES A FOLLOW UP REPORT WE WILL RE-OPEN THE CASE AND A FOLLOW UP REPORT WILL BE SUBMITTED. UF/IMPORTER REPORTER# CHANGED FROM 3003442380-2011-00017 TO 3003442380-2011-00020 AFTER REQUEST FROM FDA.

    Description of Event or Problem · 1

    (B)(6) PASSED AWAY ON OR ABOUT (B)(6) 2009. REPORTER STATED THAT (B)(6) RECEIVED A IN-APPROPRIATE AND IN-CORRECT AMOUNT OF INSULIN WHICH RESULTED IN HER PASSING OUT AND FALLING AND STRIKING HER HEAD WITH SUFFICIENT FORCE TO CAUSE HER DEATH. (B)(6) WAS A RESIDENT OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION SET QUICK SET PARADIGM FPA UNOMEDICAL DEVICE S.A. DE C.V. MMT-397 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death