DRIVEMEDICAL 795BURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00822383221649), received between Jan 18, 2019 and Jul 10, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2024Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO STATED THE BRAKES DID NOT HOLD CAUSING THE END USER TO FALL. THE END USER HAS FALLEN MULTIPLE TIMES. THE END USER STATED SHE HAD MULTIPLE CORTISONE INJECTIONS TO HER BACK AND FEET. THE INSTURCTIONS FOR USE FOR THE ROLLATOR STATES," REGULARLY TEST THE BRAKES. ALWAYS ENGAGE AND DISENGAGE WHEEL LOCKS ON BOTH SIDES SIMULTANEOUSLY. YOU MAY NEED TO ADJUST THE BRAKE SYSTEMS FROM TIME TO TIME AS THEY WILL WEAR OUT WITH NORMAL USE." AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Fall

  MAUDE report 19715878 ↗
• MalfunctionMay 24, 2023Failure to Advance; Failure to Advance

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR/TRANSPORT CHAIR BY A PROVIDER, WHO STATED "IT WILL LOCK WHEN TRYING TO PUSH IT," WHICH REPORTEDLY CAUSED THE END USER TO FALL, BUT "HER CAREGIVER GRABBED HER." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995018 ↗
• InjuryNov 10, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED "HER MOTHER WAS WALKING OUT TO HER CAR FOR AN APPOINTMENT AND THE FRONT CASTER KICKED OUT FROM UNDER HER AND WAS WOBBLY CAUSING HER TO FALL AND HIT HER HEAD." SHE REPORTEDLY RECEIVED AN "EGG" ON HER HEAD AND WENT TO THE HOSPITAL. TESTS WERE PERFORMED FOR THE HEAD INJURY, BUT THE RESULTS CAME BACK NEGATIVE. 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 15771754 ↗
• InjurySep 20, 2021Unintended Movement; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. A FOLLOW UP WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE MOVED UNEXPECTEDLY WHILE THE USER WAS GETTING OUT OF F BED TO USE THE RESTROOM. THE REPORT STATED THAT THE BRAKE FAILED TO LOCK THE WHEELS. THE USER FELL TO THE FLOOR AND WAS BRUISED. SHE WAS TAKEN TO THE HOSPITAL THE NEXT MORNING WHEN SHE COULD NOT MOVE. SHE WAS KEPT THERE FOR THREE DAYS. NOTHING WAS FOUND TO BE BROKEN. HER FAMILY PLANS TO GET HER PHYSICAL AND OCCUPATIONAL THERAPY.

  Patient problems: Easy Bruising; Fall

  MAUDE report 12497546 ↗
• InjuryMay 12, 2020Unintended Movement; Unintended Movement

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THIS REPORT IS BEING TENDERED IN AN OVERABUNDANCE OF CAUTION IN RESPONSE TO AN MDR REGRESSION ANALYSIS. END-USER HAS OWNED AND USED THE PRODUCT FOR TWO YEARS. ON TWO OCCASIONS WHEN HE WENT TO SIT ON THE DEVICE THE UNIT "FLIPPED" AND HE FELL. BOTH TIMES HE HIT HIS HEAD. AFTER INITIAL CONTACT THE END-USER AGREED TO RETURN THE UNIT FOR EVALUATION BUT DID NOT SEND IT TO US. FURTHER ATTEMPTS TO CONTACT THE END-USER WERE UNSUCCESSFUL.

  Patient problems: Fall

  MAUDE report 10046382 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WALKER. (B)(4) HAS NOT RECEIVED THE UNIT BACK FOR EVALUATION. WEIGHT CAP ON THE DEVICE IS 300 POUNDS. END-USER'S REPORTED WEIGHT IS (B)(6). END USER WAS SITTING IN THE DEVICE WHILE BEING PUSHED OUT OF DOORS. THE DEVICE HIT A BUMP IN THE PAVEMENT AND THE USER FELL OUT OF THE UNIT. SHE WAS TAKEN BY AMBULANCE TO THE MEDICAL CENTER WHERE X-RAYS WERE PERFORMED. SHE WAS INFORMED THAT SHE HAD TRAUMA IN HER LEG. SHE STAYED OVERNIGHT. THE NEXT DAY SHE HAD TROUBLE WALKING AND WENT TO ANOTHER HOSPITAL WHERE SHE WAS ADMITTED BY 4 DAY WITH A DIAGNOSIS OF HEMATOMA ON HER LEG MUSCLES. TREATMENT WAS TO ALLOW THE TRAUMA TO DISSIPATE ON ITS OWN. AFTER HOSPITAL RELEASE, END-USER FELL AGAIN WITHOUT THE USE OF THE DEVICE.

  Patient problems: Contusion

  MAUDE report 8933087 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE REPORTER NOTED THERE IS NO DAMAGE OT THE DEVICE. A CAREGIVER PUSHES THE DEVICE WHILE THE END-USER IS SITTING IN IT. ON MORE THAN ONE OCCASION THE END-USER HAS FALLEN FORWARD OUT OF THE DEVICE WHEN DEVICE IS IN MOTION .

  Patient problems: Fall; Fracture, Arm

  MAUDE report 8262540 ↗