BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1910571 · Received November 24, 2010

    Report

    Report Number
    2210968-2010-01596
    Event Type
    Death
    Date Received
    November 24, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC NEPHRECTOMY ON (B)(6) 2010. DURING THE PROCEDURE, AN UNSPECIFIED VESSEL INJURY OCCURRED AND THE PT'S BLOOD PRESSURE BEGAN TO DROP AND THE PT CODED. IT IS UNK WHAT CAUSED THE VESSEL INJURY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| L| R