MAUDE Adverse Event Report:

Model Number 5195512400

Device Problem Material Erosion (1214)

Patient Problems Emotional Changes (1831); Granuloma (1876); Pain (1994); Urinary Retention (2119); Hernia (2240); Deformity/ Disfigurement (2360); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced posterior vaginal introital mesh erosion with a perineal scarring granuloma.It is noted that this device is not placed in the posterior vagina.The patient also experienced dyspareunia, ventral umbilical hernia, vaginal atrophy, voiding dysfunction.Therefore, vaginal mesh excision with a perineal revision and cystoscopy for mild voiding dysfunction was performed under general anesthesia.

Event Description

The patient with this device experienced severe pain with daily activities and intercourse.The patient has suffered severe emotional pain and injury such as urinary incontinence, physical deformity, and the loss of the ability to perform sexually.

• MDR Report Key: 12196899
• MDR Text Key: 262502496
• Report Number: 2125050-2021-00936
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 5195512400
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female