BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 1665083 · Received April 20, 2010

    Report

    Report Number
    2647580-2010-00439
    Event Type
    Injury
    Date Received
    April 20, 2010
    Report Date
    March 24, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE OVAL DISSECTION BALLOON BURST WHILE IN PT DURING THE CASE. CONCERN WAS BROUGHT UP FOR THE POTENTIAL OF "BALLOON FRAGMENTS" LEFT BEHIND IN THE PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P9B1091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other