BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER I

    MDR report key: 46671 · Received October 30, 1996

    Report

    Report Number
    2951239-1996-00001
    Event Type
    Injury
    Date Received
    October 30, 1996
    Report Date
    October 25, 1996
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALE PT HAD A BILATERAL HERNIA REPAIR. THE SURGERY PROCEEDED NORMALLY WITH NO COMPLICATIONS DURING SURGERY. PT WAS DISCHARGED FROM THE HOSP. A FOLLOW UP TELEPHONE CALL TO THE PT REVEALED THE PT HAD NOT VOIDED SINCE LEAVING THE HOSP. ACCORDING TO THE PT, HE DID VOID AT THE HOSP PRIOR TO LEAVING. THE PT RETURNED TO THE HOSP AND WAS CATHETERIZED. APPROX 700CC OF URINE WAS COLLECTED AND BLOOD WAS PRESENT IN THE URINE. THE PT REMAINED CATHETERIZED AND RETURNED TO A UROLOGIST APPROXIMATELY 5 DAYS LATER TO HAVE THE CATHETER REMOVED. A CYSTOGRAM INDICATED A HOLE IN THE BLADDER IN THE MIDLINE REGION AND BELOW THE SYMPHYSIS PUBIS. THE HERNIA REPAIRS WERE HEALING AS ANTICIPATED AND THE PT REPORTED NO PAIN. SURGERY WAS PERFORMED TWO WEEKS AFTER THE INITIAL HERNIA SURGERY TO REPAIR THE HOLE IN THE BLADDER AND THE PT HAS REPORTED NO ADD'L COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER I BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS 1500 CC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention