BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 971273 · Received January 7, 2006

    Report

    Report Number
    1226693-2006-00005
    Event Type
    Injury
    Date Received
    January 7, 2006
    Report Date
    January 6, 2006
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    ODE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    NDO SURGICAL WAS INFORMED IN 2005 THAT DR MAY HAVE HAD A PT WITH AN ADVERSE EVENT FOLLOWING A PLICATOR PROCEDURE.) (ATTEMPTS TO CONTACT DR FOR MORE INFO WAS INITIATED. DR INDICATED THAT A FEMALE PT WHO RECENTLY RECEIVED PLICATOR TREATMENT FOR THEIR GERD HAD EXPERIENCED A PERICARDIAL EFFUSION. THE PT WAS TREATED IN HOSPITAL WITH OXYGEN AND WAS SUBSEQUENTLY RELEASED. REP WAS SUPPOSED TO PROVIDE MORE DETAILED INFO ON THE CASE BUT SHE HAS NOT RESPONDED TO OUR CONTACT ATTEMPTS AND NO FURTHER INFO HAS BEEN MADE AVAILABLE. WE ARE TAKING A CONSERVATIVE APPROACH AND FILING PRIOR TO BEING ABLE TO CONFIRM THE ABOVE STATEMENTS AND/OR OBTAINING MORE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPIC SURGICAL DEVICE ODE NDO SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention