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

Model 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	12/15/2025
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.No further evaluation can be conducted due to lack of further details.Root cause has not be 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 an intubated patient developed a stage iv upper lip pressure injury with full-thickness skin and tissue loss and exposed teeth while using the hollister anchorfast guard endotracheal tube holder.It was further reported that the wound evolved quickly and the patient required debridement of the wound and surgical repair of his lip by maxillofacial oral surgery.

• 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: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24367433
• Report Number: 1119193-2026-00005
• Device Sequence Number: 12065861
• Product Code: CBH
• UDI-Device Identifier: 00610075186518
• UDI-Public: (01)00610075186518
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: 9800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/17/2026
• 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: 60 YR
• Patient Sex: Male
• Patient Race: Black Or African American