BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAYA

    MDR report key: 9082365 · Received September 17, 2019

    Report

    Report Number
    MW5089862
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 13, 2019
    Manufacturer
    KESSEL MEDINTIM, GMBH
    Product Code
    HDW
    UDI-DI
    4013273001649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY GYN PRESCRIBED A 70MM DIAPHRAGM AND THE PHARMACIST REPLACED IT WITH A CAYA, THE PRODUCT IS TOO LARGE AND EXTREMELY UNCOMFORTABLE. CAYA IS NOT COVERED BY INSURANCE AND COSTS $(B)(6). CAYA WILL NOT REFUND THE COST, SO THEY ARE ABLE TO DISTRIBUTE THESE DEVICES WITHOUT THE CUSTOMER HAVING ANY MEANS OF RECEIVING A REFUND FOR POOR SIZING OR FAULTY PRODUCT. THE MEDICAL DEVICES IN THE UNITED STATES ARE NOT PROPERLY REGULATED, ESPECIALLY FOR WOMEN, AND BECAUSE CAYA STANDS BEHIND THE PROTECTION AFFORDED TO THEM BY THE FDA, IT SEEMS APPARENT THAT THE FDA PROTECTS THE PHARMACEUTICAL COMPANIES AND NOT THE CUSTOMER. I WROTE CAYA REQUESTING A REFUND AND THIS IS WHAT THEY WROTE TO ME "I DO APOLOGIZE FOR THE ISSUE THAT YOU ARE HAVING. THE CAYA IS MARKETED AS A "ONE SIZE FITS MOST." THIS STATEMENT IS ON ALL THE MATERIALS THAT ARE GIVEN TO PHYSICIANS AND (B)(6) WEBSITE. I AM SO SORRY THAT YOUR PHARMACIST TOLD YOU THAT BUT DUE TO THE CAYA BEING AN FDA REGULATED PRODUCT, WE ARE UNABLE TO TAKE THE DIAPHRAGM BACK AND/OR ISSUE ANY REFUNDS." HORRIBLE DISCOMFORT AND PAIN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872556 CAYA DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES) HDW KESSEL MEDINTIM, GMBH NDC63704-020-01 17U129L 10/A 4013273001649

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other