Drive R800BKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383548579), received between Mar 22, 2019 and Dec 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Human-Device Interface 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.

• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT RECEIVED, THE END USER EXPERIENCED "A SYNCOPAL EPISODE DUE TO A PRE-EXISTING CARDIAC CONDITION" WHILE USING A ROLLATOR, AND "SLUMPED OVER." THE REPORT FURTHER STATES THAT "[A]T THAT TIME, HER LEG SWUNG AROUND AND CAUGHT [A] METAL BAR ABOVE THE WHEEL, SEVERELY LACERATING HER RIGHT LOWER LEG." THE END USER RECEIVED TREATMENT INCLUDING DEBRIDEMENT AND A SKIN GRAFT, AND WAS LEFT WITH A PERMANENT SCAR. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Laceration(s)

  MAUDE report 13082957 ↗
• InjuryAug 28, 2019Unintended Movement; Unintended Movement

  (B)(4) IS THE INITIAL IMPORTER OF THIS DEVICE WHICH IS A ROLLATOR. THE CLAIM IS ONGOING. AS SUCH, UNIT WILL NOT BE RETURNED UNTIL IT IS SETTLED. THE END USER FELL ON TWO (2) OCCASIONS. THE FIRST TIME, SHE WAS SITTING DOWN, ENGAGED THE BREAKS, GOT UP, AND FELL BACKWARDS. SHE HIT HEAD ON THE NIGHT STAND AND KNEE ON THE FLOOR. THE SECOND TIME, SHE WALKING WHEN SHE ENGAGED THE BREAKS. SHE REACHED FOR THE ROLLATOR AFTER AND IT SLIPPED OUT FROM UNDER HER. SHE FELL AND COULD NOT GET UP, AND HIT HER ELBOW. HER DAUGHTER AND HUSBAND CAME AND HELPED HER UP. SHE WENT TO THE HOSPITAL WHERE X-RAYS WERE TAKEN. SHE HAD NO BROKEN BONES BUT STITCHES WERE NEEDED FOR HER ELBOW, FOOT BLACK AND BLUE. SHE GOT AN MRI, AND GOT SIMILAR RESULTS.

  Patient problems: Fall; Laceration(s)

  MAUDE report 8942565 ↗
• InjuryMar 22, 2019Human-Device Interface Problem; Human-Device Interface Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. (B)(4) WAS INFORMED OF THE INCIDENT BY AN ATTORNEY WHO HAS SINCE DROPPED THE INVESTIGATION. WE DO NOT FORSEE ACQUIRING THE ROLLATOR FOR EXAMINATION. END-USER RESIDED HOME ALONE. SHE HAD HEALTH ISSUES THAT REQUIRED HER TO TAKE COUMADIN, A BLOOD THINNING MEDICATION. SHE WAS USING THE ROLLATOR TO GET UP FROM THE COUCH TO RETRIEVE A BLANKET ON A NEARBY SOFA. THE INSIDE OF HER RIGHT LEG CAME INTO CONTACT WIITH A SHARP METAL TAB THAE WAS PART OF THE BRAKE SYSTEM. SHE SUFFERED A SERIOUS LACERATION. THE LACERATION REQUIRED STITCHES, WOUND CARE AND AN INPATIENT STAY AT THE HOSPITAL.

  Patient problems: Laceration(s)

  MAUDE report 8445265 ↗