Hugo 700-959 (UDI 00754021210886)Recalls & reported problems
Drive Devilbiss Healthcare · Rollators4-Wheel Alum Product Description: Hugo Elite Roll KD, Blue, 1EA, 2CV, Ret · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00754021210886), received between Mar 7, 2022 and Jun 12, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
Patient problems
- Abrasion1
- Bruise/Contusion1
- Easy Bruising1
- Fall1
- Myocardial Infarction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Mechanical Problem; Mechanical Problem
(B)(6) HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO STATED THE FRONT LEGS FOLD IN ON THEMSELVES AND CAUSED HIM TO FALL SEVERAL TIMES RESULTING IN MULTIPLE SCRAPES, BRUISES AND CUTS TO HIS BODY AND FACE. THE END USER REPORTED THAT HIS DOCTOR INFORMED HIM THAT HE HAD A HEART ATTACK AFTER ONE OF HIS FALLS. THE END USER DID NOT IDENTIFY HOW OR WHY THE ISSUE WAS OCCURRING. THE INJURIES HAVE NOT BEEN SPECIFIED TO DATE. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, (B)(6) HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Patient problems: Abrasion; Bruise/Contusion; Myocardial Infarction
MAUDE report 19523312 ↗InjuryMar 7, 2022Fracture; Fracture
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR ON JANUARY 27TH. THE END-USER WAS UTILIZING THE DEVICE WHILE EXITING THE BUS VIA THE STEPS. THE END USER REPORTED THAT THE LEFT REAR LEG BROKE AND SHE FELL TO THE GROUND ON TOP OF THE UNIT. SHE REPORTED THAT SHE "HAD BRUISED RIBS, LEFT LEG, ANKLE, SCRAPES ON BOTH HANDS." SHE EXPLAINED THAT "PARAMEDICS WERE CALLED SINCE IT HAPPENED AT THE BUS STATION. THEY CLEANED THE CUTS ON MY HANDS AND LEG. CHECKED FOR BROKEN BONES. I HAD BRUISED RIBS, BUT NOT BROKEN. I REFUSED TO GO TO HOSPITAL WITH TONS OF COVID PATIENTS THERE." THE END USER HAD BEEN USING THE ROLLATOR AFTER HAVING NECK SURGERY DUE TO AN UNRELATED ACCIDENT THAT CAUSED HER TO BE PARTIALLY PARALYZED DOWN HER LEFT SIDE. THE DEVICE WAS PROVIDED TO HER BY THE PREVIOUS USER. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT.
Patient problems: Easy Bruising; Fall
MAUDE report 13684387 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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