BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 2287391 · Received March 21, 2011

    Report

    Report Number
    3008007615-2011-00001
    Event Type
    Death
    Date Received
    March 21, 2011
    Date of Event
    December 4, 2010
    Report Date
    March 20, 2011
    Manufacturer
    UNK
    Product Code
    HHI
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS IDENTIFIED AFTER A NATIONAL TELEVISION BROADCAST WAS AIRED IN (B)(6) AND THEN REPORTED TO (B)(6) ON (B)(6) 2011.

    Description of Event or Problem · 1

    PATIENT WAS REPORTED TO HAVE PRESENTED AT THE CLINIC WITH COMPLAINTS OF CHEST PAIN, BREATHING PROBLEMS, BLEEDING P/V AND LOWER ABDOMINAL PAIN APPROXIMATELY 5 WEEKS AFTER PREGNANCY TERMINATION WHICH UTILIZED MANUAL VACUUM ASPIRATION METHOD (MVA). IT WAS REPORTED THAT MVA WAS PERFORMED A TOTAL OF 3 TIMES AT (B)(6). DATES OF THE PROCEDURES WERE NOT PROVIDED. THE PATIENT WAS REFERRED TO (B)(6) AND SUBSEQUENTLY EXPIRED. THE DATE OF THE DEATH WAS NOT REPORTED. A TEAM FROM (B)(6) WAS DISPENSED TO GATHER PERTINENT INFORMATION WHICH INDICATED THE PATIENT DIED DUE TO ABORTION COMPLICATION. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MANUAL VACUUM ASPIRATOR AND CANNULA HHI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death