MAUDE Adverse Event Report: KESSEL MEDINTIM, GMBH CAYA; DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)

Model Number NDC63704-020-01

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 08/27/2019

Event Type  Injury  

Event Description

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).

• Brand Name: CAYA
• Type of Device: DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)
• Manufacturer (Section D): KESSEL MEDINTIM, GMBH
• MDR Report Key: 9082365
• MDR Text Key: 159403605
• Report Number: MW5089862
• Device Sequence Number: 1
• Product Code: HDW
• UDI-Device Identifier: 4013273001649
• UDI-Public: 014013273001649
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2023
• Device Model Number: NDC63704-020-01
• Device Catalogue Number: US PATIENT # 5,771,900
• Device Lot Number: 17U129L 10/A
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 77