BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE

    MDR report key: 181057 · Received September 11, 1997

    Report

    Report Number
    2211100-1997-00002
    Event Type
    Injury
    Date Received
    September 11, 1997
    Date of Event
    October 1, 1996
    Report Date
    August 29, 1997
    Manufacturer
    R.W. JOHNSON PHARM. RESEARCH INSTITUTE DIV OF ORTHO PHARMACEUTICAL CORP.
    Product Code
    HDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS 49 YEAR OLD FEMALE REPORTS SHE HAD A LIPPES LOOP DOUBLE S INTRAUTERINE COOPER CONTRACEPTIVE INSERTED IN 1976. STATES IN OCT-96, HER PHYSICIAN DURING A GYNECOLOGICAL EXAM FOUND A MASS IN THE UTERUS AREA. SHE UNDERWENT AN EMERGENCY SURGERY IN THE LAST WEEK OF OCT-96. STATES THE UTERUS WAS PERFORATED AND SHE HAD A TOTAL HYSTERECTOMY, 9 INCHES OF INTESTINE REMOVED FROM THE ABDOMINAL AREA. A SECOND SURGERY ON 07-MAR-97, REMOVED 6 FEET OF INTESTINE DUE TO INFECTION. SHE WAS HOSPITALIZED WITH BACTERIAL INFECTION (CLOSTRIUM DIFICILE). STATES SHE HAS HAD SHORT BOWEL SYNDROME SINCE HAVING INTESTINE REMOVED. FOLLOW-UP INFO REC'D 22-JUL-97: PHYSICIAN CONFIRMED THAT IN OCT-96 THE PT PRESENTED TO DR. WITH COMPLAINTS OF SEVERE ABDOMINAL PAIN. STATES ON 27-MAR-97, THE PT PRESENTED AGAIN WITH COMPLAINTS OF ABDOMINAL PAIN FOR 12 HOURS PRIOR TO ADMISSION. EXPLORATORY SURGERY PERFORMED BY HIM REVEALS A SINGLE BAND ADHESION, WHICH CONSISTED OF A 6 FOOT GANGRENOUS BOWEL. THIS SEGMENT OF THE PT'S BOWEL SMALL INTESTINE WAS RE-SECTIONED. PT REC'D ANTIBIOTIC THERAPY (NAME NOT REPORTED). STATES THREE DAYS FOLLOWING DISCHARGE, THE PT DEVELOPED COLITIS WITH COLISTATIC DIARRHEA, REQUIRING TOTAL PARENTERAL NUTRITION (TPN) RE-HYDRATION AND QUESTRAN (CHOLESTYRAMINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE Implant IUD HDT R.W. JOHNSON PHARM. RESEARCH INSTITUTE DIV OF ORTHO PHARMACEUTICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization