DRIVEMEDICAL 12036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10822383102679), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATHTUB SAFETY RAIL BY AN END USER, WHO REPORTED THAT HE GENERALLY USES THE BATHTUB RAIL TO ASSIST IN GETTING UP FROM THE TOILET, BECAUSE HIS BATHTUB IS VERY CLOSE TO HIS TOILET. DURING THE INCIDENT, WHEN HE GRABBED THE BATHTUB RAIL TO GET UP FROM THE TOILET, IT FELL OFF THE TUB AND HE FELL, HITTING HIS HEAD AND CUTTING HIS FINGERS ON THE RAIL. THE END USER DID NOT PROVIDE ANY INFORMATION REGARDING WHAT ANGLE HE REPEATEDLY GRABBED THE BATHTUB RAIL TO ASSIST IN GETTING OFF THE TOILET, OR HOW THE BATHTUB RAIL WAS INSTALLED AT THE TIME OF THE INCIDENT. 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 15373055 ↗