93H ProFlexx® 0015762Recalls & reported problems
Ferno-Washington, Inc. · 93H ProFlexx®, Red FOF ROSA · 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 00190790000417), received between Nov 28, 2016 and Nov 28, 2016.
The most frequently reported specific device problem is “Unintended Collision” (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
- Unintended Collision1
- Unintended Movement1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Nov 28, 2016Unintended Movement; Unintended Collision; Unintended Movement
IT WAS REPORTED WHILE TRANSPORTING A (B)(6) PATIENT ON THE STRETCHER, THE STRETCHER HIT A SMALL BUMP ON THE RESIDENTS DARK PATHWAY AND THE COT ALLEGEDLY LOWERED APPROXIMATELY 12 INCHES. THERE WAS NO REPORT OF ANY INJURY TO THE PATIENT; HOWEVER, AN EMT IS ALLEGING A SHOULDER INJURY. THE COMPLAINANT WAS CONTACTED AND IT WAS REPORTED THE MEDIC SOUGHT BASIC FIRST AID FOR THE ALLEGED INJURY. AN INVESTIGATION HAS BEEN INITIATED TO EVALUATED THE REPORTED INCIDENT.
Patient problems: Injury
MAUDE report 6130534 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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