Drive 12203KD-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50822383225154), received between Jan 26, 2023 and Jul 16, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY THE PROVIDER WHO REPORTED THE BATH SEAT LEG BROKE CAUSING THE END USER TO FALL IN THE TUB. THE END USER SUSTAINED SMALL CUTS TO HER FOOT AND HAND. THE END USER WENT TO THE EMERGENCY ROOM AFTER WHAT SHE BELIEVED TO BE SIGNS OF INFECTION. THE END USER RECEIVED INTRAVENOUS ANTIBIOTICS AT THE EMERGENCY ROOM AND AT HOME AS WELL AS ORAL ANTIBIOTICS. THE END USER HAS A MEDICAL HISTORY OF IMMUNOSUPPRESSION AND REQUIRES FREQUENT ANTIBIOTIC THERAPY. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT. NEED STATEMENT FOR THE CORRECTIVE ACTIONS FOR THE REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 22522091 ↗
• DeathJan 26, 2023Material Deformation; Material Deformation

  (B)(4) WAS NOTIFIED OF AN INCIDENT INVOLVING A SHOWER CHAIR BY A LETTER FROM AN ATTORNEY, STATING THAT "THE LEGS ON THE CHAIR BENT, CAUSING THE END USER TO FALL AND HIT HIS HEAD," REPORTEDLY CAUSING HIM TO HAVE "FRACTURED HIS SPINE" AND CAUSING "PAIN IN HIS HIPS, BACK, AND HEAD." HE WAS KEPT FOR OBSERVATION IN THE HOSPITAL FOR 4 DAYS. THE PRODUCT WAS OWNED BY A HOTEL, WHERE IT WAS LENT OUT TO GUESTS SUCH AS THIS END USER, AND WAS REPORTEDLY OVER 15 YEARS OLD. (B)(4) IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING SCHEDULING AN INSPECTION, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Head Injury; Memory Loss/Impairment; Vertebral Fracture

  MAUDE report 16249393 ↗