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

Model Number	ST010
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Facility staff were trained in safe entry into the chair and instructed the patient to use the side-entry method.The patient did not follow these instructions and positioned their leg in a manner that resulted in entanglement and subsequent fracture.Staxi provided supplemental safety materials, including the instructional video, to reinforce correct staff training and usage.Manufacturer convened an internal reportable-event review on 11 nov 2025; meeting minutes, risk evaluation, and related records are maintained in the manufacturer's quality system per mdr procedure.
Event or Problem Description
The patient was educated on how to get into chair but proceeded to throw his leg to the front and it got caught between the heel bolster and the foot pedal, he then fell and broke his tibia and fibula.

• Brand Name: STAXI
• Common Device Name: STANDARD MEDICAL 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
• Manufacturer Contact: lee hancox ; 424 williamson-zebulon rd; williamson, GA 30292 ; 8776778294
• MDR Report Key: 23527834
• Report Number: 3008861771-2025-00001
• Device Sequence Number: 15724160
• Product Code: INN
• UDI-Device Identifier: 00850039103285
• UDI-Public: 00850039103285
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: ST010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/11/2025
• 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: Hospitalization
• Patient Sex: Male