BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESO-SPONGE OV.13 MM

    MDR report key: 5185145 · Received October 28, 2015

    Report

    Report Number
    2916714-2015-00976
    Event Type
    Death
    Date Received
    October 28, 2015
    Report Date
    January 19, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    EFQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE RESISTED WITHIN THE U.S. ARE. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT REPORTED IN THIS MEDWATCH REPORT OCCURRED IN (B)(6); (B)(4).

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE PATIENT HAS BEEN TREATED WITH ESOSPONGE. AFTER 8 DAYS THE PATIENT DIED, BECAUSE OF NONE STOPPABLE BLEEDINGS. 3 SPONGE EXCHANGES HAVE BEEN CARRIED OUT, THEN SUDDENLY STRONG BLEEDINGS OCCURED. WHILE A OPEN SURGICAL REVISION, VESSEL LUMEN HAVE BEEN OBSERVED. AS INFORMED BY THE DOCTOR, THE PATIENT WAS CRITICALLY ILL. IT WAS ALSO NOTED, THAT EVENTUALLY THE CHOICE OF THE TREATMENT/CARE WAS NOT OPTIMAL. PATIENT DIED BECAUSE OF BLEEDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715825 ESO-SPONGE OV.13 MM ESO-SPONGE EFQ AESCULAP AG 5526550 215223

    Patients

    Seq Age Sex Outcome Treatment
    1 Death