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

Model Number	9800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The anchorfast guard device was not saved; therefore, a device evaluation could not take place.A complaint history trend analysis was conducted for similar complaints and no adverse trends were observed.The lot number was not provided so a device history record review could not be conducted.The end user reported that they used a foam dressing under the lip foam once they noticed pressure.The ifu for this device states to discontinue use of the device if redness, skin irritation or pressure injury occurs.The account did not follow this precaution in the ifu.Hollister will conduct retraining for the account.Hollister will continue to monitor this reported issue.Since the lot number was not provided, only the di portion of the udi is known.
Event or Problem Description
It was reported that a patient who was using a hollister anchorfast guard oral endotracheal tube fastener experienced an upper lip injury.It was reported that the anchorfast guard had been in place for 16 days over multiple devices and that they used a foam dressing under the lip foam once they noticed evidence of pressure starting.In addition, they reported that the patient was sweaty, and the product was slipping.They further reported that the patient experienced a full thickness upper lip injury and required medical treatment to address.

• Brand Name: ANCHORFAST GUARD
• 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: 20923755
• Report Number: 1119193-2024-00023
• Device Sequence Number: 20904410
• Product Code: CBH
• UDI-Device Identifier: 00610075095780
• UDI-Public: (01)00610075095780
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 9800
• Device Catalogue Number: 9800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/13/2024
• 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