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

Catalog Number 0110-22

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Tissue Breakdown (2681)

Event Date 05/27/2021

Event Type  malfunction  

Event Description

Patient is a chronic g-tube patient.Has had tube for years and has been exchanged in clinic without issue/complication.A few weeks ago, patient developed redness/skin breakdown at insertion site.Believe this may be due to a change in the g-tube product we use in clinic.Reviewed with md as well who believes this may be a reaction to the type of tube used.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12092067
• MDR Text Key: 259157388
• Report Number: 12092067
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0110-22
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA
• Patient Weight: 54