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	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporting facility did not wish to be identified; therefore, hollister was unable to obtain any additional information beyond what was included in the initial fda medwatch submission.Because the lot number was not provided, 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.
Event or Problem Description
It was reported to hollister via an fda medwatch the following: upon inspection, the hollister anchorfast oral ett fastener, model 9799, was found to be defective.The issue was first identified when the patient's nurse discovered that the foam stabilization pad had detached from the main device body.The defect was detected during a routine patient assessment.The anchorfast device failed to maintain a secure and protective interface with the patient's skin and mucosa, resulting in a stage iv hapi to the upper lip and an unstageable mucosal membrane injury.The deficiency was verified by the patient's primary care team and the wound care nurse.Photographs of the injury are attached.The device appeared to have foam adhesive delamination and bonding failure between the foam pad and the plastic anchor plate, consistent with a potential material or manufacturing defect.Additionally, the event involved user deviation from the manufacturer's ifu.The root cause in multifactorial, involving both product integrity and human factors.Hollister has not received the stated photographs.

• 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: 24460928
• Report Number: 1119193-2026-00015
• Device Sequence Number: 9304483
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/26/2026
• 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