BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER I

    MDR report key: 172308 · Received June 12, 1998

    Report

    Report Number
    2951239-1998-00003
    Event Type
    Injury
    Date Received
    June 12, 1998
    Date of Event
    May 14, 1998
    Report Date
    June 12, 1998
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BLADDER INJURY WHILE PERFORMING BILATERAL INGUINAL HERNIA REPAIR. BLADDER TEAR WAS REPAIRED BY UROLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER I BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS 900 CC 802040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention