BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE

    MDR report key: 112515 · Received August 5, 1997

    Report

    Report Number
    2211100-1996-00006
    Event Type
    Other
    Date Received
    August 5, 1997
    Report Date
    March 7, 1997
    Manufacturer
    R.W. JOHNSON PHARM. RESEARCH INSTITUTE
    Product Code
    HDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 45 YR OLD FEMALE PT REPORTS SHE HAD A LIPPES LOOP DOUBLE AND INTRAUTERINE DEVICE INSERTED IN 4/96. STATES HER MENSES IS CURRENTLY 13 DAYS LATE. PT CONFIRMED WITH PHYSICIAN THE NAME OF THE DEVICE. PT'S PHYSICIAN RECONFIRMED THE DEVICE WAS A LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE. FOLLOW-UP INFO RECEIVED 1/21/97: PHYSICIAN REPORTS THAT TO HIS KNOWLEDGE NO ADVERSE EVENTS OCCURRED WHILE USING A LIPPES LOOP IN ANY OF HIS PTS. ADD'L INFO RECEIVED 3/6/97: PT REPORTS THERE WAS NO PROBLEM WITH THE LIPPES LOOP. STATES IT WAS HER SYSTEM AS A CHANGE IN CYCLE. THERE WAS NO PREGNANCY.

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NONE REPORTED