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

Catalog Number	9799
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in the medwatch that the patient sustained a pressure injury to the upper lip, likely from mechanical ventilation/ett holder (anchor fast).In addition, it was reported in the medwatch that necrotic tissue extended from the lip into the mucosal surface of the inner lip.Further, it was reported in the medwatch that necrosis on the upper lip wound was healing but full thickness defect remained.It was reported in the medwatch that debridement was completed on the upper lip open wound and reconstruction with complex layered closure was completed.
Additional Manufacturer Narrative
Attempts to obtain additional information from the facility have been made.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.

• Brand Name: ANCHORFAST
• Common Device Name: 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: 25161847
• Report Number: 1119193-2026-00039
• Device Sequence Number: 20998030
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 9799
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/13/2026
• 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