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

Model Number SR1B

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 02/28/2023

Event Type  malfunction  

Event Description

Patient was scheduled for anal manometry study on [redacted date].During second part of procedure (balloon expulsion testing), after the balloon was filled with appropriate amount of water, the patient stood up and the catheter fell out leaving the balloon inside of the patient.The balloon was manually deflated and removed manually by md.Study was able to be completed without further complications.

• Brand Name: MUI SCIENTIFIC
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): H & A MUI ENTERPRISES INC; 4221 picadilly drive; fort collins CO 80526
• MDR Report Key: 16572257
• MDR Text Key: 311583350
• Report Number: 16572257
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SR1B
• Device Catalogue Number: SR1B
• Device Lot Number: 221109-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 72 KG
• Patient Race: Black Or African American