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

Model Number	9799
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The anchorfast device was not saved; therefore, a device evaluation could not take place.A dhr review was conducted based on the lot number provided and the records were found to be complete and accurate.A complaint history trend analysis was conducted for similar complaints and no adverse trends for surgical intervention from upper lip injury were observed.A root cause could not be determined.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that a patient with an anchorfast endotracheal tube fastener in place sustained an upper lip injury.It was further reported that the injury was full thickness, and the top lip became detached and required surgical repair.It was additionally reported that the patient was believed to have worn the anchorfast device for approximately 24-48 hours.It was also reported that the patient had significant underlying medical conditions.

• Brand Name: ANCHORFAST
• Common Device Name: ORAL ENDOTRACHEAL TUBE FASTENER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 23543106
• Report Number: 1119193-2025-00042
• Device Sequence Number: 21234827
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766(17)300401(30)12(10)5D182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 9799
• Device Catalogue Number: 9799
• Device Lot Number: 5D182
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown