BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE

    MDR report key: 184536 · Received August 11, 1998

    Report

    Report Number
    2211100-1997-00009
    Event Type
    Injury
    Date Received
    August 11, 1998
    Date of Event
    June 21, 1972
    Report Date
    May 27, 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
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER ALLEGES LIPPES LOOP INSERTED 1972. REMOVED 3 MONTHS LATER DUE TO EMBEDMENT. UNDERWENT HYSTERECTOMY IN 1977. MEDICAL RECORDS FORWARDED BY CONSUMER 7/10/1989: UNSPECIFIED IUD REMOVED UNDER GENERAL ANESTHESIA 6/21/1972. 26 YEAR OLD, 3 CHILDREN, HOSPITALIZED 8/29 - 7/4/1998. SEEN IN EMERGENCY ROOM WITH CHRONIC PELVIC INFLAMMATORY DISEASE. HISTORY OF NUMEROUS VISITS FOR PELVIC PAIN AND APPARENT PELVIC INFECTION. UNDERWENT ABDOMINAL HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY 8/30/1978. LEFT TUBE AND OVARY NORMAL. PATHOLOGY REPORT: SECRETORY ENDOMETRIUM, UTERUS; MODERATE CERVICAL DYSPLASIA; FOLLICULAR AND LUTEAL CYSTS, RIGHT OVARY; CHRONIC SALPINGITIS, RIGHT. FOLLOW-UP RECEIVED 10/30/1997; PT HAD LEFT OVARY FALLOPIAN TUBE REMOVED 7/11/1997. BEING TREATED WITH HORMONE MEDICATION AND CREAM. (REPORT PREVIOUSLY MFR. #89104345.) FOLLOW-UP RECEIVED 5/26/1998: PT'S MIDDLE INITIAL AND DATE OF BIRTH PROVIDED.

    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 20 YR Hospitalization