35X-ST ProFlexx® 0015791Recalls & reported problems
Ferno-Washington, Inc. · 35X-ST ProFlexx®, Blue · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190790000363), received between Mar 4, 2017 and Apr 8, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Unintended Movement” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Unintended Movement1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THE DEVICE WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT WHILE TRANSPORTING A PATIENT. THE STRETCHER WAS REPORTED AS TO HAVING REMAINED LOCKED IN THE FASTENING SYSTEM THROUGHOUT; HOWEVER, THE PATIENT IS ALLEGING A NECK INJURY, AS A RESULT OF THE ACCIDENT. NO FURTHER DETAILS HAVE BEEN PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14056654 ↗InjuryMar 4, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Unintended Movement
COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT ON THE COT, MEDIC #1 LOST CONTROL OF THE COT WHEN HIS HANDS, WET FROM RAIN, ALLEGEDLY SLIPPED OFF THE HANDLES. MEDIC #2 ATTEMPTED TO ASSUME THE WEIGHT OF THE COT AND ALLEGEDLY SUFFERED A BACK INJURY AS A RESULT. THE TRANSPORT WAS COMPLETED AND THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT TO THE PATIENT. MEDIC #2 WAS SEEN AND TREATED AT THE ER AND THEN REFERRED TO AN ORTHOPEDIC PHYSICIAN FOR FURTHER CARE. MEDIC #2 WILL BE OFF WORK FOR A MINIMUM OF 180 DAYS.
Patient problems: Injury
MAUDE report 6378978 ↗
Other Stretcher, Wheeled devices
- Power-PRO 6506Stryker Corporation · STRETCHER, WHEELED5 deaths472 reports
- Procedural stretcher P8000HHill-Rom de México, S. de R.L. de C.V. · STRETCHER, WHEELED361 reports
- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 death251 reports
- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 recall199 reports
- Power-PRO 2, High Configuration 650705550001Stryker Corporation · STRETCHER, WHEELED2 recalls2 deaths99 reports
- NA 1089Stryker Corporation · STRETCHER, WHEELED175 reports
- NA 5050Stryker Corporation · STRETCHER, WHEELED1 recall99 reports
- Power-PRO 2 650700000000Stryker Corporation · STRETCHER, WHEELED2 recalls1 death42 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page