BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)

    MDR report key: 3393609 · Received September 9, 2013

    Report

    Report Number
    2242843-2013-00696
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    September 3, 2013
    Manufacturer
    JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB)
    Product Code
    HDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) WAS RETURNED TO THE MANUFACTURER FOR AN EVALUATION.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHARMACIST, AND CONCERNS A (B)(6). THE PATIENT'S WEIGHT AND HEIGHT WERE NOT KNOWN. HER MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED TO KNOWN ALLERGIES OR DRUG ALLERGIES. ON (B)(6) 2013, THE PATIENT BEGAN TREATMENT WITH THE ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE), (HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES), SIZE NOT SPECIFIED, (LOT NUMBER B06EU1, EXPIRATION AUGUST-2015) ONE DIAPHRAGM AS NEEDED/INTRAVAGINAL, FOR BIRTH CONTROL. CONCOMITANT MEDICATIONS WERE NOT REPORTED. A PHARMACIST CALLED TO REPORT A PRODUCT QUALITY COMPLAINT AND ADDITIONALLY REPORTED AN ADVERSE EVENT ON BEHALF OF THE PATIENT. ON AN UNSPECIFIED DATE IN 2013, THE PATIENT NOTED A HOLE IN THE DIAPHRAGM (MALFUNCTION). NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT OUTCOME WAS NOT KNOWN FOR HOLE IN DIAPHRAGM AND UNCOMFORTABLE. PATIENT USE OF THE ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) WAS ONGOING AT THE TIME OF THIS REPORT. THIS REPORT WAS ASSOCIATED WITH (B)(4). THIS REPORT WAS SERIOUS AND REPORTABLE (MALFUNCTION) (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446916 ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) HDW JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) UNK B06EU1

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other