InjuryFNL
RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Jun 10, 2026 · Event occurred May 1, 2026
Report 1931307-2026-00002 · MDR key 25456988
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Limb Fracture
Narrative
Additional Manufacturer Narrative
THE HOSPITAL IS UNWILLING TO RELEASE THE BEDFRAME OR MATTRESS TO AGILITI FOR TESTING. THEREFORE, ROOT CAUSE CANNOT BE ESTABLISHED. FURTHER INFORMATION IS CONTAINED WITHIN COMPLAINT- (B)(4).
Description of Event or Problem
A PATIENT ELEVATED A BED FRAME INDEPENDENTLY, ATTEMPTED TO EXIT, AND SUBSEQUENTLY FELL, RESULTING IN A FRACTURE OF THE TIBIA AND FIBULA.