35X ProFlexx® 0015700Recalls & reported problems
Ferno-Washington, Inc. · 35X ProFlexx®, Red w/Univ Side Arm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190790000318), received between Dec 20, 2016 and Dec 20, 2016.
The most frequently reported specific device problem is “Collapse” (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
- Collapse1
- Noise, Audible1
- Unintended Movement1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Dec 20, 2016Unintended Movement; Collapse; Unintended Movement; Noise, Audible
IT WAS REPORTED WHILE UNLOADING THE PATIENT AND STRETCHER FROM THE AMBULANCE THE MEDICS ALLEGE THEY HEARD A LOUD POP WHEN LOWERING THE WHEELS AND THE COT ALLEGEDLY CAME OUT OF THE AMBULANCE AND COLLAPSED. THE MEDIC CREW WAS ABLE TO CATCH THE STRETCHER BEFORE IT LOWERED TO THE GROUND OR TIPPED OVER. THE PATIENT WAS CHECKED FOR INJURIES AND THE STRETCHER WAS PLACED INTO POSITION AND THE TRANSPORT CONTINUED. ONCE IN THE HOSPITAL A RN WAS ADVISED OF THE INCIDENT AND THE COT WAS REMOVED FROM SERVICE ON ARRIVAL BACK TO THE STATION. AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE THE STRETCHER AND THE DETAILS OF THE REPORTED INCIDENT. NO RELATED INJURIES HAVE BEEN REPORTED TO DATE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6190239 ↗
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- 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.
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