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Drive 10233Recalls & reported problems

Drive Devilbiss Healthcare · Clever-Lite LS Rollator, w/ 5",1/cs · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383118550), received between Nov 29, 2021 and Jul 7, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Fracture1

Patient problems

  • Hip Fracture1
  • Laceration(s)1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 7, 2022Fracture; Fracture

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER'S SPOUSE REPORTED THAT "THE FRONT LEG COLLAPSED YESTERDAY. MY HUSBAND IS NOW IN THE HOSPITAL WITH A HIP FRACTURE AND IS AWAITING HIP SURGERY." THE REPORT WAS IN THE FORM OF A COMMENT ON AN E-COMMERCE WEBSITE, AND DRIVE IS THEREFORE UNABLE TO CONTACT THE END USER DIRECTLY TO ARRANGE FOR INSPECTION OF THE UNIT OR OBTAIN FURTHER INFORMATION REGARDING THE INCIDENT. DRIVE WILL FILE AN UPDATE TO THIS REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Patient problems: Hip Fracture

    MAUDE report 14948531 ↗
  • InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE END-USER ROLLED OUT OF BED AND LANDED ON HER ROLLATOR. SHE WAS IMPALED ON THE WHEELLOCK OF HER ROLLATOR. THE DEVICE WAS STUCK IN HER LEG FOR APPROXIMATELY AN HOUR UNTIL IT WAS REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: Laceration(s)

    MAUDE report 12881966 ↗

Other WALKER, MECHANICAL devices

All WALKER, MECHANICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.