BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPPES LOOP

    MDR report key: 434826 · Received December 20, 2002

    Report

    Report Number
    1316626-2002-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2002
    Date of Event
    August 31, 1984
    Report Date
    November 26, 2002
    Manufacturer
    FEI PRODUCTS, LLC.
    Product Code
    HDT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN 1981, PATIENT HAD A LIPPES LOOP INSERTED. AFTER INSERTION THEY SUFFERED A SERIES OF FREQUENT INFECTIONS. THEY, AT A LATER DATE, BECAME PREGNANT. THE IUD WAS NOT REMOVED BECAUSE THE STRINGS WERE NOT VISIBLE. IN 1984, THE PATIENT GAVE BIRTH TO A HEALTHY BABY. THE PATIENT RECEIVED TREATMENT FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPPES LOOP PLASTIC INTRAUTERINE CONTRACEPTIVE DEVICE HDT FEI PRODUCTS, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization