MAUDE Adverse Event Report: HOLLISTER INCORPORATED ANCHOR FAST; DEVICE, FIXATION, TRACHEAL TUBE

Model Number	9799
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt had a 0.5 cm x 2.0cm unstageable pressure injury to the upper lip/mustache.Had the anchor fast device on.Required debridement and surgical closure by plastic surgery.The product was applied to the patient on (b)(6) 2017 and the date of the injury was (b)(6)2017.

• Brand Name: ANCHOR FAST
• Common Device Name: DEVICE, FIXATION, TRACHEAL TUBE
• Manufacturer (Section D): HOLLISTER INCORPORATED; libertyville IL 60048
• MDR Report Key: 6416701
• Report Number: MW5068527
• Device Sequence Number: 537022
• Product Code: CBH
• UDI-Device Identifier: 00610075000975
• UDI-Public: (01)00610075000975
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 83