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

Model Number	9799
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the upper lip stabilizer on the hollister anchorfast oral endotracheal tube fastener detached leading to skin damage to the upper lip.It was further reported that the damage went through to the inside of the upper lip which has resulted in numbness and nerve involvement for the patient post critical care.
Additional Manufacturer Narrative
The lot number was not provided so a device history record review could not be performed.The device was not returned, making sample evaluation impossible, and no photographs were made available for review.As a result, the root cause of the reported upper lip stabilizer separation and upper lip pressure injury could not be determined.Only the di portion of the udi was available due to the absence of lot-specific information.

• Brand Name: ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER
• Common Device Name: ANCHORFAST
• 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: 24654482
• Report Number: 1119193-2026-00018
• Device Sequence Number: 5664495
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model 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: 03/16/2026
• Initial Report FDA Received Date: 03/20/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown