MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORGRIP TUBE RETENTION SYSTEM; DH CPK CORGRIP TUBE RETENTION

Model Number	25-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 09 jun 2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
Event or Problem Description
Avanos medical inc.Received a single report that referenced different incidents, which were associated with separate units, involving different patients.This is the second of two reports.Refer to 3011270181-2026-00084 for the first report.The customer reported a pressure injury associated with use of a tube retention system.Additional information received on may 20, 2026, reported that the retention tether became embedded in the patient's skin, with skin reportedly growing over the tether.The condition was identified during removal of the feeding tube and retention system on (b)(6) 2026.The device had reportedly been placed at another facility on (b)(6) 2026.No patient demographic information, medical intervention details, or patient outcome information were provided.

• Brand Name: CORGRIP TUBE RETENTION SYSTEM
• Common Device Name: DH CPK CORGRIP TUBE RETENTION
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): MEDICAL MURRAY, INC.; 540 capital drive; suite 150; lake zurich IL 60047
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 25448993
• Report Number: 3011270181-2026-00085
• Device Sequence Number: 21209924
• Product Code: KNT
• UDI-Device Identifier: 00350770005997
• UDI-Public: (01)00350770005997
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 25-010
• Device Catalogue Number: 25-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown