MAUDE Adverse Event Report: HOLLISTER, INC ENDOTRACHEAL TUBE ATTACHMENT DEVICE; DEVICE, FIXATION, TRACHEAL TUBE

Model Number	9799
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Malposition of Device (2616); Protective Measures Problem (3015)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.Lot number not provided, so a dhr cannot be performed.Root cause was unable to be determined.Additional information was requested, but as of the date of this report there has been no response.Hollister will continue to monitor for this type of issue in our post-market surveillance system.
Event or Problem Description
A report was received from a nurse that a patient using the anchorfast oral endotrach tube fastener reportedly sustained an injury.It was reported that the patient developed a hole in the lip.No further information available.

• Brand Name: ENDOTRACHEAL TUBE ATTACHMENT DEVICE
• Common Device Name: DEVICE, FIXATION, TRACHEAL TUBE
• Manufacturer (Section D): HOLLISTER, INC; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER, INC.; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville 60048
• MDR Report Key: 24179222
• Report Number: 1119193-2026-00002
• Device Sequence Number: 9569882
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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: 9799
• Device Catalogue Number: 9799
• Device Lot Number: UNKNOWN
• 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: 01/07/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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: Other
• Patient Sex: Unknown