35X ProFlexx® 0015693Recalls & reported problems
Ferno-Washington, Inc. · 35X ProFlexx®, Blue · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190790000301), received between Sep 30, 2016 and Feb 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment Of Device Component1
Patient problems
- Abrasion1
- Fall1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE COT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT WHILE TRANSPORTING A PATIENT. IT WAS ALLEGED THE PATIENT AND MEDIC CREW SUSTAINED INJURIES AS A RESULT OF THE ACCIDENT AND MEDICAL INTERVENTION WAS SOUGHT. THE COMPLAINANT DID REPORT THE COT REMAINED IN THE FASTENER THROUGHOUT THE INCIDENT. AN EVALUATION OF THE COT HAS NOT BEEN REQUESTED. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE COT BEING A CONTRIBUTING FACTOR TO THE INCIDENT OR THE ALLEGED INJURIES.
Patient problems: Injury
MAUDE report 7237433 ↗Sep 30, 2016Detachment Of Device Component
IT WAS REPORTED WHILE ROLLING THE COT ALONG A SIDEWALK AT A RETAIL LOCATION, ONE OF THE REAR WHEELS OF THE COT ALLEGEDLY BECAME DETACHED CAUSING THE COT TO TIP WITH A PATIENT ON BOARD. NO MEDICS WERE INJURED; HOWEVER, IT WAS REPORTED THE PATIENT ALLEGEDLY SUSTAINED AN ABRASION TO THE ARM. THE TRANSPORT WAS ABLE TO BE COMPLETED WITH NO DELAY. THE ER STAFF AT THE HOSPITAL WAS ADVISED OF THE INCIDENT AND THE ALLEGED INJURY; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED INDICATING ANY NEED FOR TREATMENT OF THE ALLEGED INJURY. AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE THE REPORTED INCIDENT.
Patient problems: Abrasion; Fall
MAUDE report 5990673 ↗
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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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