MAUDE Adverse Event Report: H A MUI ENTERPRISES INC MUI SCIENTIFIC; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	SR1B
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse inserted balloon and catheter into the rectum and inflated balloon.Patient was unable to deliver balloon into commode.Nurse deflated balloon and remove catheter.Balloon was found to have been missing from the catheter.Upon evaluation it was noted that patient had retained balloon in rectum.A flexible sigmoidoscopy had to be performed to remove the balloon.

• Brand Name: MUI SCIENTIFIC
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): H A MUI ENTERPRISES INC; 4221 picadilly drive; fort collins CO 80526
• MDR Report Key: 18865185
• Report Number: 18865185
• Device Sequence Number: 20866980
• Product Code: FFX
• UDI-Device Identifier: 00678467000774
• UDI-Public: (01)00678467000774
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/19/2023
• Report Date (Section F): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR1B
• Device Lot Number: 230718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Date Report Sent to FDA: 12/19/2023