drive 12011KD-1ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383004655), received between Feb 22, 2023 and Feb 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH BY AN END USER'S WIFE, WHO STATED THAT "HER HUSBAND WAS ON THE TRANSFER BENCH WHEN THE LEG SNAPPED. HE FELL AND HIT HIS HEAD AND BECAME UNCONSCIOUS FOR A COUPLE OF MINUTES." THE END USER DID NOT SEEK MEDICAL ATTENTION. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Head Injury; Loss of consciousness

  MAUDE report 16421611 ↗