MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. SARA FLEX; LIFT, PATIENT, NON-AC-POWERED

Model Number	HEB0000-98
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A resident lost balance during a transfer from bed to an electric wheelchair using arjo sara flex lift and arjo sling after her left knee shifted within the calf support during the standing phase.The caregiver was able to catch the resident and guide her safely to the ground; however, the legs remained secured behind the calves in the support, resulting in pressure being applied to the resident¿s knee.The resident sustained a knee fracture that required surgery.The device inspection did not reveal any product malfunction.The device operated correctly.

• Brand Name: SARA FLEX
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• MDR Report Key: 25370807
• Report Number: 1419652-2026-00098
• Device Sequence Number: 15772745
• Product Code: FSA
• UDI-Device Identifier: 05056097354941
• UDI-Public: (01)05056097354941(11)250905
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026
• Report Date (Section F): 06/03/2026

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: Other
• Device Model Number: HEB0000-98
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/11/2026
• Device Age: 8 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 06/03/2026