BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL-FLEX ARCING SPRING DIAPHRAGM

    MDR report key: 1671180 · Received April 20, 2010

    Report

    Report Number
    2211100-2010-00006
    Event Type
    Other
    Date Received
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    ORTHO-MCNEIL PHARMACEUTICAL CORP
    Product Code
    HDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM LITERATURE. VON MOLLENDORF CE, VAN DAMME L, MOYES JA, REES VH, CALLAHAN MM, MAUCK CK, ET AL. RESULTS OF A SAFETY AND FEASIBILITY STUDY OF THE DIAPHRAGM USED WITH ACIDFORM GEL OR KY JELLY. CONTRACEPTION 2010;81:232-239. THE PT'S MEDICAL HISTORY, HEIGHT AND WEIGHT WERE UNK. THE PT WAS ENROLLED IN A RANDOMIZED, PLACEBO-CONTROLLED SAFETY AND FEASIBILITY TRIAL OF A DIAPHRAGM WITH VAGINAL GEL DURING 6 MONTHS OF USE AMONG 120 HIV-NEGATIVE SEXUALLY ACTIVE WOMEN. THE WOMEN RECEIVED AN ORTHO ALL-FLEX ARCING SPRING DIAPHRAGM MADE OF NATURAL RUBBER ALONG WITH ACIDFORM GEL FOR THE PREVENTION OF PREGNANCY. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNSPECIFIED DATE THE PT BECAME PREGNANT. THE PT OUTCOME WAS UNK. THIS REPORT IS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL-FLEX ARCING SPRING DIAPHRAGM HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES HDW ORTHO-MCNEIL PHARMACEUTICAL CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other