Tek RMD 03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811478030020), received between Sep 10, 2024 and Sep 10, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device 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. How this data works · Data updated Oct 13, 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 10, 2024Use of Device Problem; Use of Device Problem

  THE USER ASKED TO USE THE TEK RMD TO EVALUATE ITS SUITABILITY. HE WAS INSTRUCTED ON THE SAFE USE OF THE DEVICE AND DID MEET THE CRITERIA FOR USER SUITABILITY AS DESCRIBED IN THE IFU. DURING THE TRIAL USE HE MADE A TURN AND FELL ONTO THE FLOOR. THE USER WAS IN THE DEVICE WHEN IT FELL TO THE MATTED SURFACE OF THE THERAPY GYM. THE DEVICE WAS LIFTED UPRIGHT BY THOSE WHO OBSERVED THE INCIDENT. THE USER WAS THEN ASSISTED TO GET OUT OF THE DEVICE. A SKIN TEAR WAS OBSERVED ON HIS ARM AND BRUISING WAS OBSERVED AT HIS HIP. THE USER LEFT THE THERAPY GYM, AND HE STATED THAT HE WAS GOING TO A LOCAL HOSPITAL ER FOR EXAMINATION. AFTER THE EVENT, THE SALES REPRESENTATIVE WAS INFORMED BY THE THERAPY GYM MANAGER THAT THE USER HAD POSSIBLY BEEN DIAGNOSED WITH A HIP FRACTURE (DIAGNOSIS HAS NOT BEEN INDEPENDENTLY CONFIRMED AT THIS TIME).

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 20184964 ↗