MAUDE Adverse Event Report: MINNESOTA TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Two minnesota tubes failed to deflate in the gastric balloon.

• Brand Name: MINNESOTA TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 18969450
• MDR Text Key: 338577588
• Report Number: 18969450
• Device Sequence Number: 1
• Product Code: KNT
• 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: 03/04/2024,07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White