MAUDE Adverse Event Report:

Model Number 5195512400

Device Problems Material Erosion (1214); Output Problem (3005)

Patient Problems Emotional Changes (1831); Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Numbness (2415); Prolapse (2475); Dysuria (2684); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional information received on 18nov2020 reported that as of (b)(6) 2020, the patient experienced recurrent vaginal pain, recurrent uti, intermittent pain (inguinal, bilateral pelvic area, medial thighs) that is worse with certain activities, and oab.Additional information received on 02dec2020 reported a complete removal of eroded aris on (b)(6) 2017.The patient experienced a uti on (b)(6) 2018.Additional information received on 24apr2021 reported that between 08mar2020 and 02mar2021 the patient experienced urinary frequency and urgency, uti, low back pain, pelvic pain, numbness to clitoris and labia, low back pain, numbness and pain to labia and clitoris, pain also occurs in feet, genitalia, groin, and hip.Pain worse after exercise, intercourse, and lifting.Obturator nerve compression.Pudendal neuralgia.Urinary urgency, pain: vaginal, inguinal bilateral pelvic area, and medial thigh.Diffuse mild tenderness to palpation of superficial and deep levator ani muscles.Overactive bladder, urethral spasms, pelvic discomfort, mild fatigue, inner thigh and pelvic pain that radiates to her lower tailbone, groin, and right leg and into big toe.Stress incontinence, overactive bladder including sensory urgency, daytime frequency, and urge incontinence; dyspareunia; pain and decreased sensation with defecation.Additional information received on 11may2021 reported that as of (b)(6) 2021, the patient experienced stress incontinence; pain in right labia, clitoris, groin, urethra, and inner thighs to knees; overactive bladder including sensory urgency, daytime frequency, and urge incontinence; dyspareunia; pain and decreased sensation with defecation.Additional information received on 31may2021 reported the patient experienced vaginal odor, uti symptoms/urinary frequency likely due to bladder prolapse, cystitis, dysuria.

Event Description

This report is a follow-up to mfr#: 2125050-2020-00097.

Event Description

Additional information received further reported that the patient had increased pelvic pain with diminished functional capacity.She could not cook, clean, read, and experienced difficulty eating, which contributed to her post traumatic stress disorder.The patient had traveled and was experiencing intense pain from traveling and from a clinical exam, and also reported increased emotional trauma associated with both her clinical exam and prior history of abuse.

• Manufacturer Contact: usaby angela kilian
• MDR Report Key: 12313745
• MDR Text Key: 266372555
• Report Number: 2125050-2021-01138
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 3264265
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female