BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 2001692 · Received February 22, 2011

    Report

    Report Number
    2647580-2011-00117
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED A HAND-WRITTEN COPY OF A MEDWATCH FILLED BY THE ACCOUNT, HOWEVER IT DOES NOT CONTAIN A UF/IMPORTER REPORT #.

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR/TEP. PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: THE DISSECTION BALLOON DETACHED FROM THE TROCAR INSIDE THE PT. THE PERITONEUM WAS TORN. THE ENTIRE DEVICE WAS RETRIEVED FROM THE CAVITY. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS 1 HOUR DELAY REPORTED. TISSUE WAS REPORTED TO BE DAMAGED. NO BLEEDING REPORTED. ORIGINAL PROCEDURE INGUINAL HERNIA REPAIR/TEP. DUE TO TORN PERITONEUM PROCEDURE TURNED TO A TAP. TAP WAS UNMANAGEABLE SO THE PROCEDURE WAS CONVERTED TO OPEN. IT COULD NOT BE REPORTED IF THE PERITONEUM WAS TORN WITH THE 1ST OR 2ND DEVICE. PT WAS DISCHARGED SAME DAY.

    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 P0J0993

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R| S