MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORGRIP* SR NG/NI TUBE RETENTION SYSTEM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	26-010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
New bridle is less flexible than previous brand, strings to tie in a knot are worse quality and do not stay tied, posing a risk for dislodgment.Overall seems worse quality and harder to insert and utilize.

• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 24616674
• Report Number: 24616674
• Device Sequence Number: 9834214
• Product Code: KNT
• UDI-Device Identifier: 00350770005614
• UDI-Public: (01)00350770005614
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/03/2026
• Report Date (Section F): 02/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: 26-010
• Device Catalogue Number: 26-010
• Device Lot Number: C2460986F
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/04/2026