BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO PH CAPSULE DELIVERY DEVICE

    MDR report key: 5006625 · Received August 13, 2015

    Report

    Report Number
    9710107-2015-00224
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT SENT: 1/8/2016. THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATING THAT THE PRODUCT WAS RELEASED MEETING FINISHED PRODUCT SPECIFICATIONS. IN ADDITION, TRENDING IS PERFORMED ON A REGULAR BASIS AS OUTLINED IN (B)(4): HANDLING COMPLAINTS TO IDENTIFY WHETHER THE TRENDING HAS HIT TRIGGERS THAT REQUIRE ADDITIONAL INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BRAVO CAPSULE FAILED TO DETACHED FROM THE ESOPHAGUS. SITE PHYSICIAN LEANING TOWARD CAPSULE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532192 BRAVO PH CAPSULE DELIVERY DEVICE BRAVO FFT GIVEN IMAGING LTD. FGS-0313

    Patients

    Seq Age Sex Outcome Treatment
    1