NATURA+
Received Apr 24, 2026
Report 3005778470-2026-00587 · MDR key 24977936
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Female
- Bacterial Infection
Narrative
Description of Event or Problem
THE END USER REPORTED THAT ON ONE OCCASION, EFFLUENT LEAKED THROUGH THE POUCH FILM WHILE SHE WAS SHOWERING, RESULTING IN CONTACT WITH HER VAGINAL/PERINEAL AREA. SEVERAL DAYS LATER, SHE BEGAN FEELING UNWELL AND DEVELOPED URINARY FREQUENCY. SHE SOUGHT CARE AT AN URGENT CARE FACILITY, WHERE URINE AND VAGINAL CULTURES WERE PERFORMED. SHE REPORTED THAT VAGINAL CULTURES WERE NEGATIVE, WHILE URINE CULTURES WERE POSITIVE FOR BACTERIAL GROWTH. SHE WAS PRESCRIBED AMOXICILLIN/POTASSIUM CLAVULANATE 875/125 MG TO BE TAKEN EVERY TWELVE HOURS FOR SEVEN DAYS. FOLLOWING THE EVENT, THE PATIENT CONTINUED TO USE THE PRODUCT BUT CHANGED THE APPLIANCE. NO PHOTO IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SEVERE INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.