DRIVEMEDICAL 146-RTL12027RARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612479221994), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Installation-Related 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.

• InjuryNov 10, 2021Installation-Related Problem; Installation-Related Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A TOILET SEAT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL FILE A FOLLOW-UP SUBMISSION WHEN ADDITIONAL DATA IS AVAILABLE. THE ELEVATED TOILET SEAT WAS INSTALLED IMPROPERLY. THE CLAMP WAS TIGHTENED IN THE INCORRECT LOCATION. THE USER FELL ONTO HER KNEES AND HIT HER HEAD ON THE WALL. SHE RECEIVED BRUISES ON HER KNEES AND ELBOWS. SHE DID NOT SEEK MEDICAL ATTENTION AS A RESULT OF THESE INITIAL INJURIES. THE FOLLOWING DAY SHE HAD LEG PAIN AND TRIED TO WALK BUT FELL. THE DAY AFTER THE SECOND FALL, THE USER CALLED AN AMBULANCE BECAUSE THEY WERE UNABLE TO WALK. AN XRAY DETERMINED THAT THE FEMUR BALL JOINT WAS COMPLETELY DETACHED. THE USER HAD SURGERY 2 DAYS LATER TO REPLACE HER HIP. SHE WAS PRESCRIBED OXYCODONE, MORPHINE, AND FENTANYL FOR PAIN.

  Patient problems: Fall; Hip Fracture

  MAUDE report 12791748 ↗