BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE MORCELLEX UNKNOWN PRODUCT

    MDR report key: 18903006 · Received March 14, 2024

    Report

    Report Number
    2210968-2024-03054
    Event Type
    Death
    Date Received
    March 14, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A PATIENT'S FAMILY MEMBER THAT INNOVATIVE MORCELLATOR WAS THE REASON THE PATIENT DIED. NO FURTHER INFORMATION WAS PROVIDED AND NO FURTHER INFORMATION COULD BE OBTAINED AS THE REPORTER CONTACT DETAILS WERE NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454184 GYNECARE MORCELLEX UNKNOWN PRODUCT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death