35X-NM ProFlexx® 0015788Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190790000349), received between Dec 28, 2016 and Jul 18, 2025 — 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Unintended Movement; Unintended Movement

  A PRODUCT ISSUE ON THE SUBJECT STRETCHER WAS REPORTED VIA MEDSUN REPORT #(B)(4) ALLEGING A WHEEL LOCK ISSUE BUT NO SPECIFIC PATIENT INCIDENT OR INJURY WAS ASSOCIATED WITH THE ISSUE. UPON FURTHER INVESTIGATION WITH THE END USER, IT WAS DISCOVERED THE EVENT ASSOCIATED WITH THE SUBJECT STRETCHER INVOLVED RESTRAINTS AND NOT A WHEEL LOCK ISSUE. IT WAS REPORTED WHILE TRANSPORTING A PATIENT ON THE STRETCHER TO AN MRI TRAILER, THE PATIENT'S WEIGHT SHIFTED WHILE TRAVERSING A THRESHOLD AND THE STRETCHER TIPPED OVER. REPORTED PATIENT INJURY INCLUDED ABRASIONS TO NOSE, ARMS, KNEES AND TOES. THE PATIENT WAS NOT RESTRAINED TO THE STRETCHER AT THE TIME OF INCIDENT NOR WERE THE PROVIDED RESTRAINTS INSTALLED ON THE STRETCHER AT THE TIME OF INCIDENT. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION CONTRIBUTING TO THE INCIDENT AND THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED ON THE PATIENT'S INJURIES. THE END USER CONDUCTED AN INTERNAL INVESTIGATION WHICH INCLUDED A CORRECTIVE ACTION TO INSTALL THE PROVIDED RESTRAINTS ONTO THE STRETCHER BEFORE PLACING IT BACK IN SERVICE.

  Patient problems: Abrasion

  MAUDE report 22542838 ↗
• Dec 28, 2016Use of Device Problem; Use of Device Problem

  IT WAS REPORTED WHILE LIFTING THE FRAME OF THE COT TO RELEASE THE LOCKING MECHANISM, A MEDIC ALLEGEDLY INJURED THEIR BACK WHEN THE MECHANISM WOULD NOT RELEASE. THERE WAS A PATIENT ON THE COT AT THE TIME OF INCIDENT BUT THERE WERE NO REPORTS OF INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT. THE INITIAL REPORT OF THE INCIDENT INDICATED THE MEDIC DID NOT SEEK MEDICAL INTERVENTION FOR THE ALLEGED INJURY BUT RATHER USED ICE AND REST. IT WAS LATER REPORTED ON 12/23/2016 THAT THE MEDIC WAS GOING TO SEEK MEDICAL TREATMENT FOR THE ALLEGED INJURY DUE TO ONGOING PAIN.

  Patient problems: Injury; Pain

  MAUDE report 6208287 ↗