MAUDE Adverse Event Report: HOLLISTER INCORPORATED ANCHORFAST GUARD; ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER

Catalog Number	9800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Device history review could not be conducted because the lot number was not provided.Root cause has not been determined.Only the di of the udi information was provided because the lot number was not known.
Event or Problem Description
It was reported that a skin injury was observed beneath the adhesive barrier cheek pad during removal of the hollister anchorfast guard device.It was reported that the device had been in place for 7 days and during a period of that time, the patient had been placed in the lateral position.It was reported that a medicated ointment and a skin barrier were used as treatment for the injury.Hollister has since provided education to the account.

• Brand Name: ANCHORFAST GUARD
• Common Device Name: ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: rebeca thomas ; 2000 hollister drive; libertyville, IL 60048-3781 ; 2246022874
• MDR Report Key: 24749193
• Report Number: 1119193-2026-00035
• Device Sequence Number: 9100927
• Product Code: CBH
• UDI-Device Identifier: 00610075186518
• UDI-Public: (01)00610075186518
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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 Catalogue Number: 9800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 83 KG