BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUTURE UNKNOWN

    MDR report key: 8697004 · Received June 13, 2019

    Report

    Report Number
    2210968-2019-82718
    Event Type
    Death
    Date Received
    June 13, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAO
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR FATHERS OPERATIVE REPORT TO REVIEW THE TYPE OF SUTURE AND WHICH LAYER OF TISSUE THE SUTURE WAS USED? NO. DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR FATHER¿S SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT THE SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION?

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER ON SOCIAL MEDIA THAT THE PATIENT UNDERWENT SURGERY FOR AORTA ANEURYSM ON UNKNOWN DATE IN 1990¿S AND UNKNOWN SUTURE WAS USED. ON AN UNKNOWN DATE POSTOPERATIVELY THE PATIENT EXPERIENCED INFECTION ¿ALL OVER¿ AND EXPIRED ON AN UNKNOWN DATE IN THE 1990'S. THE FAMILY REPORTED THAT THE SURGEON OPINED THAT THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490780 SUTURE UNKNOWN SUTURE, NON ABSORBABLE, SYNTHETIC GAO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death