35X-ST ProFlexx® 0015794Recalls & reported problems
Ferno-Washington, Inc. · 35X-ST ProFlexx®, Blue 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190790000387), received between May 22, 2019 and May 22, 2019 — classified as 1 injury.
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
- Unintended Movement1
Patient problems
- Bruise/Contusion1
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2019Unintended Movement; Unintended Movement
THE COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT ON THE STRETCHER, THE STRETCHER HIT UNEVEN PAVEMENT WHILE ROTATING THE STRETCHER AND THE UNIT THEN ALLEGEDLY TIPPED OVER WITH THE PATIENT. THE PATIENT ALLEGES A BRUISE TO THEIR LEFT ELBOW HOWEVER; NO TREATMENT WAS SOUGHT AS A RESULT.
Patient problems: Bruise/Contusion; Fall
MAUDE report 8632156 ↗
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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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