MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

G-tube device found dislodged.Balloon appears to be ruptured.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14073477
• MDR Text Key: 288988414
• Report Number: 14073477
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2022
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Female