Enema Ring: Fluid Collection Device 901101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815112020955), received between Oct 31, 2023 and Oct 31, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023

  PATIENT PRESENTED TO THE ED WITH RECTAL BLEEDING. PATIENT HAVING BRIGHT RED STOOL WITH CLOTS (APPROX. 250ML). DUE TO CONTINUOUS LOOSE STOOLS PATIENT WAS PLACED ON AN ENEMA RING FOR FECAL CONTAINMENT. THE DAY SHIFT NURSE TURNED THE PATIENT AND NOTED SKIN IRRITATION AROUND HER BUTTOCK. MEPILEX BANDAGES WERE PLACED TO KEEP AREA CLEAN AND DRY. PROVIDER WAS MADE AWARE AND AFTER SEEING PATIENT SKIN IRRITATION ADVISED NURSE TO KEEP COVERED WITH BANDAGES. NURSE REPORTED IN DOCUMENTATION PATIENT STATES SHE HAS SENSITIVE SKIN REGARDING SOAPS AND LOTIONS. PATIENT HAD EMBOLIZATION IN IR AND WAS THEN ON A GO LYTELY BOWEL PREP FOR COLONOSCOPY WHILE IN THE ED AND WAS ADMITTED TO THE HOSPITAL FOR ACUTE GI BLEEDING AND COLONSCOPY PROCEDURE. WOUND CARE NURSE PICTURES OF PATIENT DURING INITIAL WOUND ASSESSMENT REVEAL A LINEAR BREAK IN SKIN INTEGRITY IN A CIRCULAR PATTERN AROUND BUTTOCKS AREA. THE ENEMA RING (INFLATED) HAS A 'STIFF' SEAM PROTRUDING APPROXIMATELY HALFWAY BETWEEN THE TOP AND BOTTOM OF THE RING ON THE INSIDE. THIS SEAM IS ROUGH FEELING WHEN HAND IS RUBBED ACROSS THE SEAM.

  Patient problems: Embolism/Embolus; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 18038936 ↗