BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILICONE LIKE DEVICE

    MDR report key: 2369718 · Received December 9, 2011

    Report

    Report Number
    MW5023393
    Event Type
    Death
    Date Received
    December 9, 2011
    Report Date
    December 9, 2011
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS THAT (B)(6), DIED AT (B)(6) HOSPITAL AFTER A URINARY EMBOLIZATION PROCEDURE. SHE SAID, THE PT WAS NOT A CANDIDATE FOR THIS PROCEDURE BECAUSE THE TUMOR IN HER UTERUS WAS ONLY 20CM AND THE DOCTOR DID NOT FOLLOW PROTOCOL. BEFORE AND DURING PROCEDURE, PT HAD NO TRANSLATOR AND THE HOSPITAL DISCHARGED HER WITH NO F/U. WHEN SHE RETURNED WITH COMPLICATIONS, SHE WAS DENIED READMISSION AND REFERRED TO SMALLER HOSPITALS. HOSPITAL DID NOT FILE ANY REPORT ON PT AND RPTR SAID PT WAS POKED MORE THAN ONCE. SHE DEMANDS A FULL INVESTIGATION INTO THE MATTER BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE LIKE DEVICE UTERINE EMBOLIZATION NAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death