BEUDAMED
    FDA Adverse Event Summary report: N

    LIPPED LOOP DOUBLE S INTRAUTERINE DEVICE

    MDR report key: 71766 · Received February 24, 1997

    Report

    Report Number
    2211100-1996-90005
    Date Received
    February 24, 1997
    Date of Event
    October 7, 1996
    Report Date
    November 4, 1996
    Manufacturer
    R.W. JOHNSON PHARM RESEARCH INSTITUTE DIV. OF ORTHO PHARMEACEUTICAL CORP.
    Product Code
    HDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A 45 YEAR OLD FEMALE PT REPORTS SHE HAD AN 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 THE CO'S INTRAUTERINE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR