BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)

    MDR report key: 1908962 · Received November 26, 2010

    Report

    Report Number
    2211100-2010-00024
    Event Type
    Other
    Date Received
    November 26, 2010
    Date of Event
    May 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB)
    Product Code
    HDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT RECEIVED FROM A PT CONCERNS A (B)(6) YEAR-OLD FEMALE FROM THE UNITED STATES: (B)(4) THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED: DRINKS ALCOHOL (1 WINE WEEKLY) AND NON SMOKER. THE PT'S WEIGHT WAS 105 POUNDS AND HEIGHT WAS 60 INCHES. THE PT HAD PREVIOUSLY EXPERIENCED ALLERGIES WHEN TAKING SULFA DRUGS. OTHER MEDICAL HISTORY INCLUDED NO KNOWN ALLERGIES AND NO DRUG ABUSE/ILLICIT DRUG USE. THE PT BEGAN USING ORTHO ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) IN (B)(6) 2010. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT REPORTED THAT SINCE SHE BEGAN USING THE DIAPHRAGM IN (B)(6) 2010, SHE HAS BEEN EXPERIENCING "SEVERAL BLADDER INFECTIONS." SHE ALSO STATED THAT SHE HAS BEEN PRESCRIBED AN UNSPECIFIED ANTIBIOTIC FOR TREATMENT. THE PT IS STILL USING THE DIAPHRAGM. THE PT OUTCOME WAS UNK FOR THE BLADDER INFECTIONS. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES HDW JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other