BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREPERITONEAL DISTENTION BALLOON

    MDR report key: 145763 · Received January 20, 1998

    Report

    Report Number
    2939738-1997-00043
    Event Type
    Injury
    Date Received
    January 20, 1998
    Date of Event
    December 19, 1997
    Report Date
    December 19, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FGY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC BILATERAL HERNIA, A PT'S BLOOD VESSEL WAS TORN. THE PRODUCT USED AT THE TIME WAS NOT KEPT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPERITONEAL DISTENTION BALLOON PREPERITONEAL DISTENTION BALLOON FGY ORIGIN MEDSYSTEMS, INC. OMS-XB2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R