MAUDE Adverse Event Report: BTL INDUSTRIES JSC EMSELLA; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE FOR INCONTINENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Micturition Urgency (1871); Muscle Weakness (1967); Discomfort (2330); Dysuria (2684); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2023

Event Type  Injury  

Event Description

I underwent three treatments with the emsella device at (b)(6) to improve my urinary incontinence condition.I read about the treatment online and thought i would be a good candidate.The first treatment was on (b)(6) 2022 and the other two treatments were done within the following 10 days.After the first treatment, i felt some discomfort in my urethra, but it subsided before the next treatment.I told the technician and she lowered the intensity for the second treatment.After the second treatment, i had increased discomfort.I felt like i had to urinate all the time and didn't feel relief after urinating.Again it subsided after a couple of days.I tried one more treatment, thinking that this reaction was normal, as the technician assured me.After the third treatment, my discomfort increased significantly.I felt pain when urinating, along with the constant urge to evacuate my bladder.I had to use uristat to relieve the pain, but it persisted.Two days later, i went to an urgent care facility, complaining that i thought i had a bladder infection.They prescribed macrodantin and took a culture, which was later found to be negative (no bacterial growth).My condition did not improve, and i went to my gynecologist, who prescribed a different antibiotic and also took a culture, with the same negative results.As recommended by my gynecologist, i subsequently saw a urologist, who diagnosed my condition as atrophic urethritis and vaginitis, and after a detailed examination, he attributed the cause to the emsella treatments, which caused abrasion between the urethra and vaginal walls by imposing its stimulating vibrations.He prescribed an insertable estradiol cream, which helped the discomfort subside after several applications, and the pain ultimately went away.The period of time i suffered with pain and discomfort was about one month.After seeing the urologist, i reported his findings to the technician at (b)(6), cancelled the remainder of the treatment program, and requested a refund for the unused sessions.I was granted the refund, but i feel it important to report to the fda the adverse reaction that i experienced to the emsella treatments.I hope to prevent other women who may have atrophy of the urethra and vaginal walls from suffering the four weeks of extreme discomfort that i did as a result of the emsella treatments.Reference reports: mw5118108, mw5118109.

• Brand Name: EMSELLA
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE FOR INCONTINENCE
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 17057766
• MDR Text Key: 316638153
• Report Number: MW5118110
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DAILY VITAMIN, CALCIUM, COLACE.; VESICARE, ATORVASTATIN.
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White