MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY INC. G-JET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Patient Problem Failure of Implant (1924)

Event Date 04/05/2023

Event Type  Injury  

Event Description

The balloon that holds my gj (gastrostomy-jejunostomy) feeding tube in place popped after only being in for 5 weeks.They typically last more than 12.

• Brand Name: G-JET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY INC.
• MDR Report Key: 17809352
• MDR Text Key: 324271121
• Report Number: MW5146104
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability