DRIVEMEDICAL RTL12027RARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383246260), received between Dec 20, 2019 and Feb 21, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  FROM MDR 2438477-2025-00002: DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN ELEVATED TOILET SEAT BY A LETTER FROM AN ATTORNEY, ALLEGING THAT IT BECAME LOOSE AND CAUSED THE END USER TO FALL. NO SPECIFIC DEFECT HAS BEEN IDENTIFIED. THE END USER SUSTAINED A BROKEN FEMUR THAT REQUIRED SURGERY. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Limb Fracture

  MAUDE report 21431146 ↗
• InjuryJan 8, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN ELEVATED TOILET SEAT BY A LETTER FROM AN ATTORNEY, ALLEGING THAT IT BECAME LOOSE AND CAUSED THE END USER TO FALL. NO SPECIFIC DEFECT HAS BEEN IDENTIFIED. THE END USER SUSTAINED A BROKEN FEMUR THAT REQUIRED SURGERY. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Limb Fracture

  MAUDE report 21107070 ↗
• MalfunctionApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A RAISED TOILET SEAT BY AN END USERS' WIFE, WHO REPORTED THAT THE LOCKING MECHANISM ON THE FRONT OF THE SEAT HAS CUT HER HUSBAND'S LEG ON SEVERAL OCCASIONS. 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: Laceration(s)

  MAUDE report 16724228 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ELEVATED TOILET SEAT. THE DEVICE HAS NOT BEEN RETURNED. IT HAS NOT BEEN EVALUATED. DEVICE IS AN ELEVATED TOILET SEAT WITH METAL REMOVABLE METAL ARMS. END-USER LEANED TO THE SIT WHILE ON THE DEVICE. HE FELL AND HIT HIS HEAD AND CUT OPEN HIS ARM. HE WAS TAKEN TO THE EMERGENCY ROOM.

  Patient problems: Fall; Laceration(s)

  MAUDE report 9500747 ↗