SARA FLEX HEB1000Recalls & reported problems
Arjohuntleigh AB · SARA FLEX with Scale - Standing and raising aid and transfer aid - Powered · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05056097354958), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Use of Device Problem; Use of Device Problem
THE PATIENT WAS ASSESSED TO TRANSFER USING THE SARA FLEX. SHE HAD BEEN SUCCESSFULLY TRANSFERRING WITH THE SARA FLEX. ON SATURDAY (B)(6) 2024 THE PATIENT WAS NO LONGER ABLE TO SUPPORT HERSELF AS WELL CAUSING THE SLING TO RIDE UP UNDER HER ARMS. THE TRANSFER FROM THE TOILET WAS COMPLETED. THE PATIENT COMPLAINED OF SORE UPPER ARMS. LATER SHE WAS TRANSFERRED TO THE HOSPITAL AND WAS DEMONSTRATED THAT SHE HAD VASCULAR INJURY OF THE UPPER ARM. THE PATIENT SUSTAINED CHEST WALL HEMATOMA THAT REQUIRED HOSPITALIZATION
Patient problems: Hematoma
MAUDE report 19391890 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.