BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 4171439 · Received October 14, 2014

    Report

    Report Number
    2647580-2014-00868
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC HERNIA REPAIR. ACCORDING TO THE REPORTER: BALLOON BURST AS SURGEON WAS INFLATING IT DURING THE LAP INGUINAL HERNIA REPAIR.** (B)(6). *** ADDITIONAL INFORMATION REQUESTED VIA EMAIL *** 1. WERE ALL PIECES OF THE BALLOON RECOVERED? 2. WHAT SURGICAL PROCEDURE WAS BEING PERFORMED? 3. WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM? 4. WAS THERE ANY TISSUE DAMAGE AS A RESULT OF THIS PROBLEM? A. IF YES, DESCRIBE THE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED. B. WAS THE DAMAGE IRREVERSIBLE? 5. WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM? 6. DID ANY ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM REQUIRE A BLOOD TRANSFUSION? 7. WAS SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM? 8. WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY? (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC.?) 9. HOW IS THE PATIENT CURRENTLY?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650542 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMSPDB1000 P3M0404X

    Patients

    Seq Age Sex Outcome Treatment
    1