35X ProFlexx® 0015690Recalls & reported problems
Ferno-Washington, Inc. · 35X ProFlexx®, Red · Class 2
Data updated Oct 16, 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 00190790000295), received between May 10, 2018 and May 10, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2018Positioning Problem; Positioning Problem
IT WAS REPORTED WHILE UNLOADING A PATIENT FROM THE AMBULANCE AT THE HOSPITAL, THE LEGS OF THE COT ALLEGEDLY WOULD NOT DISENGAGE. THE PATIENT WAS REMOVED FROM THE COT AND WALKED INSIDE THE HOSPITAL. THERE WERE NO REPORTS OF INJURY OR ADVERSE EFFECT TO THE PATIENT OR CREW AS A RESULT OF THE INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7503403 ↗
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- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 recall199 reports
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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