BEUDAMED
    FDA Adverse Event Summary report: N

    PREPERITONEAL DISSECTION BALLOON

    MDR report key: 18559 · Received December 28, 1994

    Report

    Report Number
    MW1004585
    Date Received
    December 28, 1994
    Date of Event
    December 7, 1994
    Report Date
    December 7, 1994
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    KOG
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING PRE-PERITONEAL LAPAROSCOPIC HERNIA REPAIR. AFTER INSERTING BALLOON TO DO BALLOON DISSECTION, BALLOON RUPTURED DURING INFLATION PROCESS. HAD TO CONVERT TO INTRA-PERITONEAL LAPAROSCOPIC PROCEDURE. RPTR WAS UNABLE TO RECONSTRUCT BALLOON SO IS UNSURE IF ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPERITONEAL DISSECTION BALLOON KOG ORIGIN MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *