BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE

    MDR report key: 171930 · Received June 10, 1998

    Report

    Report Number
    2211100-1998-00023
    Event Type
    Injury
    Date Received
    June 10, 1998
    Date of Event
    January 1, 1995
    Report Date
    May 22, 1998
    Manufacturer
    R.W. JOHNSON PHARM. RESEARCH INSTITUTE/DIV. OF ORTHO PHARMACEUTICAL CORP
    Product Code
    HDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORT FROM 54 YEAR OLD FEMALE PT WHO HAD A LIPPES LOOP INTRAUTERINE DEVICE INSERTED IN 1974 AND IN 1995 DEVELOPED A PELVIC ABSCESS FOR WHICH SHE HAD A HYSTERECTOMY. SHE WAS TOLD BY HER PHYSICIAN THE DEVICE COULD BE LEFT IN UNTIL POST-MENOPAUSE. PT HAD PAPANI COLAOU SMEAR APPROX EVERY 2 YEARS. SHE IS NOW ON HORMONES. DENIES MEDICAL OR GYNECOLOGICAL HISTORY. ON NO OTHER MEDICATION AT THAT TIME.

    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 54 YR Hospitalization