MAUDE Adverse Event Report: BRACCO DIAGNOSTICS INC ENEMA RING: FLUID COLLECTION DEVICE; CATHETER, RETENTION, BARIUM ENEMA WITH BAG

Model Number	901101
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Skin Tears (2516); Embolism/Embolus (4438); Skin Inflammation/ Irritation (4545)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: ENEMA RING: FLUID COLLECTION DEVICE
• Common Device Name: CATHETER, RETENTION, BARIUM ENEMA WITH BAG
• Manufacturer (Section D): BRACCO DIAGNOSTICS INC; 259 prospect plains road; monroe township NJ 08831
• MDR Report Key: 18038936
• Report Number: 18038936
• Device Sequence Number: 8171643
• Product Code: FGD
• UDI-Device Identifier: 10815112020955
• UDI-Public: (01)10815112020955
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023
• Report Date (Section F): 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 901101
• Device Catalogue Number: 901101
• Device Lot Number: 60404437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 05/22/2023