MAUDE Adverse Event Report: SONESTA MEDICAL AB SONESTA; SONESTA 6210

Model Number	0120-LA120-03
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The model 6210 includes detachable arm rests intended for patient comfort and arm positioning during clinical procedures.The arm rests are not structural components and are not designed to support patient body weight or function as safety rails.The reported event occurred during post-procedure patient handling when the patient was leaned against a detachable arm rest.The manufacturer determined that the event was related to use of the arm rest outside its intended purpose and that current instructions for use do not sufficiently describe arm rest limitations.Corrective actions are being implemented to update risk management documentation and clarify arm rest use and limitations in the ifu.
Event or Problem Description
During post-procedure patient care, a paraplegic patient was repositioned while seated on a model 6210 procedure chair.During dressing, the patient was leaned against a detachable arm rest.The arm rest is intended for patient comfort and arm positioning and is not designed to support patient body weight.During this maneuver, the arm rest attachment came loose, and the patient fell from the chair to the floor.Two healthcare staff members sustained back injuries while attempting to prevent the fall.One staff injury required medical care and resulted in work restrictions.The patient was evaluated following the fall and no acute injury was reported.

• Brand Name: SONESTA
• Common Device Name: SONESTA 6210
• Manufacturer (Section D): SONESTA MEDICAL AB; industrivägen 7; solna, stockholm 171 4 8; SW 171 48
• Manufacturer (Section G): SONESTA MEDICAL AB; industrivägen 7; solna, stockholm 171 4 8; SW 171 48
• Manufacturer Contact: nicke ersson ; industrivägen 7; solna, stockholm 171 4-8 ; SW 171 48
• MDR Report Key: 24018512
• Report Number: 3010496070-2026-00001
• Device Sequence Number: 10531680
• Product Code: IXR
• UDI-Device Identifier: 07350006950018
• UDI-Public: 07350006950018
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: Health Professional
• Device Model Number: 0120-LA120-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White