Drive R800RDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383524115), received between Feb 19, 2020 and Sep 7, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2022Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT WHILE USING THE ROLLATOR, THE RIGHT WHEEL FELL OFF," CAUSING HER TO FALL AND HIT HER HEAD, AND SUSTAINED "BRUISES ON A LOT OF HER BODY INCLUDING HEAD, NECK, ARMS, ARMPIT, DOWN HER SIDE ETC.," BUT THAT NO BONES WERE BROKEN. THE END USER REPORTED THAT "MAINTENANCE" AT HER ASSISTED LIVING FACILITY TOLD HER THAT THE THREADING FOR THE REAR AXLE IS STRIPPED. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Head Injury

  MAUDE report 15374371 ↗
• InjurySep 13, 2021Sharp Edges; Sharp Edges

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WALKER. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE END-USER HAS RECEIVED LACERATIONS WHEN SHE BUMPS UP AGAINST THE SIDE BOLTS ON THE OUTSIDE OF THE CROSS FRAME ON THE ROLLATOR WHEN HER SKIN RIPS IT TAKES A MONTH FOR HER LEGS TO HEAL SINCE A WOUND SPECIALIST MUST BE ENGAGED.

  Patient problems: Laceration(s)

  MAUDE report 12463065 ↗
• InjuryFeb 19, 2020Adverse 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 RETRIEVED FOR INSPECTION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. REPORTEDLY THE ROLLATOR BRAKE CONTROL CABLES FAILED WHILE IN USE CAUSING THE END-USER TO FALL TO THE FLOOR. THE INJURIES SUSTAINED WERE ADDRESSED BY SURGICAL MEANS.

  Patient problems: Fall

  MAUDE report 9729887 ↗