Drive 10109Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383100159), received between Feb 19, 2021 and Feb 19, 2021 — 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.

• InjuryFeb 19, 2021Use of Device Problem; Use of Device Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WALKER. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. WE HAVE NOT RECEIVED THE UNIT BACK FOR EVALUATION SINCE THE INCIDENT WAS CAUSED BY USER ERROR. INITIAL DAMAGE TO THE DEVICE OCCURRED IN 2015 THE DEVICE WAS USED AFTER DAMAGE. THE DEVICE WAS INITIALLY DAMAGED IN AN INCIDENT ON 2015 CAUSED BY THE END-USER'S MEDICAL CONDITION. THE END-USER CONTINUED TO USE THE DEVICE AFTER MULTIPLE INCIDENTS ON WHICH HE SUFFERED MINOR INJURIES. IN THIS INCIDENT THE END-USER FELL, WAS TAKEN TO THE EMERGENCY ROOM BY AMBULANCE AND TREATED FOR A GASH ON THE HEAD. AT THE TIME OF THIS INCIDENT THE DEVICE WAS 8 YEARS OLD.

  Patient problems: Fall; Laceration(s)

  MAUDE report 11350062 ↗