BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 2507533 · Received March 23, 2012

    Report

    Report Number
    2647580-2012-00182
    Event Type
    Injury
    Date Received
    March 23, 2012
    Report Date
    February 10, 2012
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON RUPTURED. PT NOT HARMED. PT (B)(6) OLD. ADD'L INFO REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/OVAL BALLOON DISSECTOR SM PLUS BALLOON GCJ USSC PUERTO RICO P1H0560

    Patients

    Seq Age Sex Outcome Treatment
    1