MAUDE Adverse Event Report: SECURISYN MEDICAL SUNMED LLC; SOLIDAIRITY FLEX ORAL ENDOTRACHEAL TUBE STABILIZER

Model Number	4.1500.2DS
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
We are seeing on occasion, the upper lip of the patient getting pinched by the large foam pad under the positioning track.The injury occurred from the pad pression against the patient's teeth.
Additional Manufacturer Narrative
The patient was injured by the pad pression.
Additional Manufacturer Narrative
The patient was injured by the pad pression.Summary: investigation into reported complaints (b)(6) indicate a lack of system requirements during design and product launch.Revision of the design input/output files are being conducted for airlife product acquisition.Ra: no associated risk management files for solidairity product owned by airlife at time of clinical trials.
Event or Problem Description
We are seeing on occasion, the upper lip of the patient getting pinched by the large foam pad under the positioning track.The injury occurred from the pad pression against the patient's teeth.

• Brand Name: SUNMED LLC
• Common Device Name: SOLIDAIRITY FLEX ORAL ENDOTRACHEAL TUBE STABILIZER
• Manufacturer (Section D): SECURISYN MEDICAL; 609 s. university blvd #631010; littleton CO 80163
• Manufacturer (Section G): SECURISYN MEDICAL, LLC; 9609 s. university blvd; littleton CO 80163
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17195280
• Report Number: 1314417-2023-00016
• Device Sequence Number: 20657851
• Product Code: CBH
• UDI-Device Identifier: 00860009077928
• UDI-Public: 00860009077928
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 4.1500.2DS
• Device Catalogue Number: 4.1500.2DS
• Device Lot Number: SY230420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown