BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARYLAND

    MDR report key: 845245 · Received April 19, 2007

    Report

    Report Number
    845245
    Event Type
    Injury
    Date Received
    April 19, 2007
    Date of Event
    March 12, 2007
    Report Date
    April 19, 2007
    Manufacturer
    GIMMI GMBH
    Product Code
    HCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH DYSFUNCTIONAL UTERINE BLEEDING. SHE UNDERWENT TOTAL LAPARASCOPIC HYSTERECTOMY AND BSO AND CYSTOSCOPY WITH NO APPARENT PERIOPERATIVE COMPLICATIONS. SHE WAS DISCHARGED HOME ON POST OPERATIVE DAY (POD) #2. ON POD #4 SHE PRESENTED WITH NAUSEA AND VOMITING AND WAS ADMITTED. SHE DEVELOPED A FEVER. CT SCAN SHOWED ABDOMINAL ABSCESS. THREE DAYS LATER SHE UNDERWENT EXPLORATORY LAPARATOMY, REPAIR OF COLONIC PERFORATION AND END COLOSTOMY. SHE WAS DISCHARGED HOME NINE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND ESU, BIPOLAR FORCEP HCZ GIMMI GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention