Mp23-13 Female External Catheter for Managing Urinary Incontinence Device Complication Trends: Does It Hurt More Than Help?

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence (MP23)1 May 2024MP23-13 FEMALE EXTERNAL CATHETER FOR MANAGING URINARY INCONTINENCE DEVICE COMPLICATION TRENDS: DOES IT HURT MORE THAN HELP? Aaron Tverye, Taylor Bate, Evan Fruhauf, Johnathan Drevik, Jennifer Anger, and Colby Souders Aaron TveryeAaron Tverye , Taylor BateTaylor Bate , Evan FruhaufEvan Fruhauf , Johnathan DrevikJohnathan Drevik , Jennifer AngerJennifer Anger , and Colby SoudersColby Souders View All Author Informationhttps://doi.org/10.1097/01.JU.0001008776.99097.8a.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Purewick® External Catheter, the first female external urinary catheter (EUC), was introduced in 2016. The innovation stemmed from a desire to create a female version of the male condom catheter with the goal of reducing the risk of recurrent UTIs (rUTIs), while at the same time managing bothersome urinary incontinence and associated skin breakdown. Data has been mixed regarding the reduction of rUTIs with this device and there is concern that the continuous suction applied by the device may exacerbate skin breakdown. We sought to evaluate early tracking data curated in the US FDA Manufacturer and User Facility Device Experience (MAUDE) database to identify potential safety issues with the device. METHODS: The FDA MAUDE database was analyzed using the advanced search tool from 2016-October 2023. Submissions related to the Purewick® device were analyzed. Data extracted included report number, event date, date received, event type, manufacturer, device problem, patient complications, and event description. RESULTS: From January 2017 - October 2023, there were 1,406 complications reported related to the use of the female EUC. 68.0% of the submissions were patient injuries, 31.6% were device malfunctions, and 0.39% of submissions linked the EUC device to patient deaths. The peak number of complications reported was in 2021 with 517 total complaints. The most common injury reported was UTI (35%) and skin inflammation/irritation (13%). See Figure 1. For device malfunctions, 24.6% were inadequate or insufficient training, 24.4% were issues with the device suction, and 10.9% were related to device overheating. CONCLUSIONS: Although the FDA MAUDE database is an imperfect data source, it provides insight into common issues and complications with devices prior to formal safety communications from the FDA. Patients interested in using the female EUC should be counseled on the possible adverse events captured by this review. Download PPT Source of Funding: N/A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e386 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Aaron Tverye More articles by this author Taylor Bate More articles by this author Evan Fruhauf More articles by this author Johnathan Drevik More articles by this author Jennifer Anger More articles by this author Colby Souders More articles by this author Expand All Advertisement PDF downloadLoading ...