MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBE, GASTRO-ENTEROSTOMY

Model Number 98701

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problems Foreign Body In Patient (2687); Skin Inflammation/ Irritation (4545)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

Updating to add original procedure date.Patient had foreign body removed from abdominal wound during wound clinic visit.Entering midas to report product to fda/medsun.Product was discovered to be t-faster utilized during g-tube placement.This appears to be a rare complication where the t-fastener migrated through the stomach and into the skin where it caused an irritation.Product is meant to be passed out through the intestinal tract after sutures are released/dissolved.

• Brand Name: AVANOS
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14120349
• MDR Text Key: 289437716
• Report Number: 14120349
• Device Sequence Number: 1
• Product Code: KGC
• 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: 04/05/2022

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
• Device Operator: Health Professional
• Device Model Number: 98701
• Device Catalogue Number: 98701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2022
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 04/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1