BEUDAMED
    FDA Adverse Event Death Summary report: N

    IPAS MVA PLUS ASPIRATOR

    MDR report key: 1700943 · Received May 26, 2010

    Report

    Report Number
    3008007615-2010-00001
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    March 9, 2010
    Report Date
    May 26, 2010
    Manufacturer
    WOMANCARE GLOBAL
    Product Code
    HHI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS AE REPORT PERTAINS TO ONE EVENT THAT OCCURRED WITH THE USE OF THE PRODUCT DESCRIBED IN THIS REPORT CONNECTED TO THE PRODUCT DESCRIBED IN MFR REPORT # 3008007615-2010-00002. THE IPAS EASY GRIP CANNULAE IS CONNECTED TO THE IPAS MVA PLUS ASPIRATOR TO PERFORM UTERINE EVACUATION PROCEDURES.

    Description of Event or Problem · 1

    THE PT UNDERWENT A UTERINE EVACUATION PROCEDURE ON (B) (6) 2010. SHE DEVELOPED FEVER AND ABDOMINAL PAIN ON (B) (6) 2010. SHE WAS TAKEN TO A REFERRAL HOSPITAL ON (B) (6) 2010. SHE DIED ON (B) (6) 2010. THE DIAGNOSIS WAS SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPAS MVA PLUS ASPIRATOR HHI WOMANCARE GLOBAL PLUS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death