MAUDE Adverse Event Report: HOLLISTER INCORPORATED ANCHORFAST GUARD; DEVICE, FIXATION, TRACHEAL TUBE

Model Number	9800
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient developed a non-stageable injury to the mucosal lip where the anchorfast was located.

• Brand Name: ANCHORFAST GUARD
• Common Device Name: DEVICE, FIXATION, TRACHEAL TUBE
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr.; libertyville IL 60048
• MDR Report Key: 17117083
• Report Number: 17117083
• Device Sequence Number: 6612083
• Product Code: CBH
• UDI-Device Identifier: 00610075070237
• UDI-Public: (01)00610075070237
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023
• Report Date (Section F): 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9800
• Device Catalogue Number: 9800
• Device Lot Number: 2L082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2023
• 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
• Patient Sex: Female
• Patient Weight: 29 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 06/07/2023