DRIVEMEDICAL RTL12447KDRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383972114), received between Nov 10, 2020 and Nov 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 10, 2020Break; Break

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH BENCH. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE DEVICE WAS RETURNED AN EVALUATED. THE END-USER WAS EXITING THE DEVICE WHEN THE FRONT LEG DETACHED. HE FELL AND HIT HIS HEAD ON THE FAUCET. HE WAS TAKEN TO THE HOSPITAL AND GIVEN X-RAYS AND A CAT SCAN. THE UNIT WAS EVALUATED BY A QUALITY ENGINEER. ONE OF THE INNER PARTS OF THE LEG DETACHED FROM THE OUTER PLASTIC FRAME. THE UNIT WAS MISSING ONE OF ITS HANDLES. THE LEG WAS SET ON THE LOWEST SETTING AND THE INDICATOR WAS BARELY VISIBLE. THERE WERE NO CRACKS OR BREAKS NOTICED ON THE UNIT. THE INNER AND OUTER CONNECTION WAS ATTACHED BY GLUE AND HAD DETACHED. POSSIBLE ROOT CAUSE WAS THAT THE USER OVER TORQUED THE LEG CAUSING THE GLUE TO BREAK. HISTORICAL DATA OF COMPLAINTS OF THE SAME NATURE WAS REVIEWED AND NONE WERE FOUND FOR THIS ISSUE. THIS SHOWS NO TREND. THIS IS CONSIDERED AN ISOLATED INCIDENT WITH ROOT CAUSE CANNOT BE DETERMINED.

  Patient problems: Fall

  MAUDE report 10820524 ↗