• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Back to Search Results
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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

MDR Report Key12196899
MDR Text Key262502496
Report Number2125050-2021-00936
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
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 Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number5195512400
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage

Patient Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1