BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 5257578 · Received December 1, 2015

    Report

    Report Number
    9710107-2015-05047
    Event Type
    Death
    Date Received
    December 1, 2015
    Report Date
    October 26, 2015
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS SENT IN ERROR. THIS MDR (9710107-2015-05047) IS A DUPLICATE OF ANOTHER REPORT (REPORT NUMBER 9710107-2015-00266). THE CORRECT REPORT IS 9710107-2015-00266.

    Additional Manufacturer Narrative · 1

    REFERENCE #: (B)(4). INITIAL REPORTER ALSO SENT REPORT TO FDA, (REPORT #: MW5044841) UNFORTUNATELY, THE INITIAL REPORTER IS UNABLE TO RELEASE ANY FURTHER INFORMATION THAT PERTAINS TO THE REPORT IN QUESTION. THEREFORE, NO ADDITIONAL INFORMATION FOR THIS REPORT IS AVAILABLE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTISTIC INDIVIDUAL WITH A HISTORY OF CONSTIPATION BECAME UNRESPONSIVE. THE PATIENT WAS RUSHED TO THE EMERGENCY ROOM AND PRONOUNCED DEAD. DURING THE AUTOPSY A PERFORATION WAS FOUND IN THE CECUM. A BRAVO CAPSULE WAS FOUND IN THE CECUM ADJACENT TO THE PERFORATION SITE. THE PERITONEAL CAVITY CONTAINED BLOOD AND FECAL MATTER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786839 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313

    Patients

    Seq Age Sex Outcome Treatment
    1 Death