FDA Adverse Event Injury Summary report: N

ENEMA RING: FLUID COLLECTION DEVICE

MDR report key: 18038936 · Received October 31, 2023

Report

Report Number
18038936
Event Type
Injury
Date Received
October 31, 2023
Date of Event
May 9, 2023
Report Date
May 22, 2023
Manufacturer
BRACCO DIAGNOSTICS INC
Product Code
FGD
UDI-DI
10815112020955
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
VA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1882132 ENEMA RING: FLUID COLLECTION DEVICE CATHETER, RETENTION, BARIUM ENEMA WITH BAG FGD BRACCO DIAGNOSTICS INC 901101 60404437 10815112020955

Patients

Seq Age Sex Outcome Treatment
1 29565 DA Female Required Intervention