MAUDE Adverse Event Report: STAXI CORP STAXI; STAXI STANDARD CHAIR

Model Number	ST010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	09/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event reportedly occurred in 2023.Staxi became aware of the event on february 16, 2026.Prior to this date, staxi had not received any complaint or notification regarding this incident.The report is being submitted within 30 days of manufacturer awareness in accordance with 21 cfr 803.50.Staxi is investigating the incident and requesting addtional information.
Event or Problem Description
Report of a front caster falling off chair whilst passenger being pushed up a incline, causing the passenger to fall from the chair.

• Brand Name: STAXI
• Common Device Name: STAXI STANDARD CHAIR
• Manufacturer (Section D): STAXI CORP; 424 williamson_zebulon rd; williamson GA 30292
• Manufacturer (Section G): STAXI CORP; 424 williamson-zebulon rd; williamson GA 30292
• MDR Report Key: 24367235
• Report Number: 3008861771-2026-00001
• Device Sequence Number: 17488083
• Product Code: KNN
• UDI-Device Identifier: 00850039103216
• UDI-Public: 00850039103216
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/15/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ST010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White