MAUDE Adverse Event Report: WATKINS-CONTI PRODUCTS, INC. YONIFIT BLADDER SUPPORT; PESSARY, VAGINAL

Model Number	PT-A-0015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Kidney Infection (4502)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The prescribing obgyn ran cultures to test for yeast and bacteria and the test results were all negative.The patient reported that she was still vomiting at this appointment.During the investigation when speaking with the patient's obgyn and a physician advisor to the manufacturer, each of the medical professionals could not confirm that the event was caused by yonifit; however, the device was being used prior to the event occurrence.Therefore, we are reporting in compliance with the mdr requirements.This is the first and only report to date received wherein the patient experienced a uti and/or kidney infection.
Event or Problem Description
After flying on friday, (b)(6), the patient stated that she experienced flu-like symptoms.Patient stated she removed the device and did not reinsert.The patient reported experiencing low-grade fever and vomiting and on monday on (b)(6), the patient reported that she saw her primary care physician.Patient reports the physician diagnosed her with uti and kidney infection.Patient reported she was treated with antibiotics.

• Brand Name: YONIFIT BLADDER SUPPORT
• Common Device Name: PESSARY, VAGINAL
• Manufacturer (Section D): WATKINS-CONTI PRODUCTS, INC.; 3900 s broadway; ste 6e; edmond OK 73013
• Manufacturer (Section G): WATKINS-CONTI PRODUCTS, INC.; 3900 s broadway; ste 6e; edmond OK 73013
• Manufacturer Contact: allison watkins ; 3900 s broadway; ste 6e; edmond, OK 73013 ; 4058129132
• MDR Report Key: 25209394
• Report Number: 3031788248-2026-00001
• Device Sequence Number: 10409286
• Product Code: HHW
• UDI-Device Identifier: 00850019563269
• UDI-Public: 850019563269
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-A-0015
• Device Lot Number: 26-241212-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White