RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Apr 3, 2026 · Event occurred Sep 16, 2023
Report 1931307-2026-00001 · MDR key 24783067
Device
Product problems
- Insufficient Device Problem Information
Patient
58 YR · Male
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE PATIENT WAS USING A BEDSIDE PATIENT LIFT TO TRANSFER OUT OF BED WHEN THE LIFT MALFUNCTIONED AND/OR BROKE CAUSING THE PATIENT TO FALL TO THE FLOOR AND FRACTURE HIS KNEE. THE TWO LIFTS THAT WERE IN USE BY THE PATIENT ARE (B)(6) (REN107506) WITH MANUFACTURE DATE OF 01-FEB-2021 AND (B)(6) (REN119300) WITH MANUFACTURE DATE OF 08-JUL-2022. BOTH LIFTS WERE THE SAME MODEL AND UDI NUMBER. THIS EVENT OCCURRED ON 16-SEP-2023. THE INITIAL NOTIFICATION RECEIVED ON 20-MAY-2024 INDICATED THAT THE PATIENT EXPERIENCED A FALL AND SUSTAINED A FRACTURED KNEE WHICH DID NOT WARRANT AN MDR AT THAT TIME. A SUBSEQUENT NOTIFICATION RECEIVED ON 05-MARCH-2026 REPORTED THAT THE PATIENT SUSTAINED SERIOUS INJURIES, THEREFORE, MDR SUBMISSION IS NOW WARRANTED.
Additional Manufacturer Narrative
SPECIFIC INJURY DETAILS HAVE NOT BEEN PROVIDED. INVESTIGATION IS CURRENTLY UNDERWAY VIA AGILITI COMPLAINT COMPLAINT-(B)(4). PRODUCT WAS RECALLED ON 02-JAN-2024 REQUESTING THAT DEVICES BE DESTROYED. THE PATIENT WAS CONTACTED THREE TIMES VIA PHONE. THE PATIENT HAS DECLINED PICKUP AND HAS NOT PROVIDED CONFIRMATION OF DEVICE DESTRUCTION.