DRIVE RTL12004KDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383246581), received between Apr 6, 2022 and Oct 31, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH STOOL BY AN END USER, WHO STATED THAT SHE "LEANED BACK TO REACH FOR SOMETHING THAT WAS BEHIND ME AND THE LEG GAVE WAY, COMPLETELY BENT. I FELL BACK LANDING ON MY COCCYX FIRST, THEN THE REST OF MY BACK AND THEN MY HEAD HIT THE CABINET." THE END USER REPORTED ICING THE AFFECTED AREA, TAKING IBUPROFEN FOR PAIN AND SEEING A CHIROPRACTOR. 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

  MAUDE report 15698944 ↗
• InjuryOct 11, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH STOOL BY AN END USER, WHO STATED THAT "I LEANED BACK TO REACH FOR SOMETHING THAT WAS BEHIND ME AND THE LEG GAVE WAY, COMPLETELY BENT. I FELL BACK LANDING ON MY BACK AND THEN THEN HIT MY HEAD." THE END USER REPORTS HAVING HAD BACK SURGERY, AND CONTINUED TREATMENT WITH A CHIROPRACTOR. 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

  MAUDE report 15576915 ↗
• InjuryApr 6, 2022Material Integrity Problem; Material Integrity Problem

  ON FEBRUARY 2, 2022, DRIVE DEVILBISS HEALTHCARE RECEIVED NOTICE OF AN ACCIDENT INVOLVING A BATH SAFETY STOOL. THE END USER'S ATTORNEY REPORTED THAT THE END USER WAS SITTING ON THE UNIT WHEN ONE OF THE LEGS "BROKE OFF," ALTHOUGH PHOTOGRAPHS INDICATE THAT ONE OF THE LEGS BENT. THE ATTORNEY REPORTED THAT THE END USER WAS INJURED AND SOUGHT MEDICAL ATTENTION, AND PROVIDED PHOTOGRAPHS OF BRUISING ON THE END USER'S LOWER LEG AND ANGLE. 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: Bruise/Contusion; Fall

  MAUDE report 14024807 ↗