Hugo 700-957 (UDI 00754021210022)Recalls & reported problems
Drive Devilbiss Healthcare · Rollators4-Wheel Alum Product Description: HUGO OPP PACIFIC BLUE, 1EA, 2CV, Ret · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00754021210022), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Use of Device Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2021Break; Use of Device Problem; Break; Use of Device Problem
DEVICE IS A ROLLATOR WHICH WAS DISTRIBUTED AT THE TIME OF MANUFACTURE BY AMG MEDICAL IN CANADA. WE HAVE NOT RECEIVED THE UNIT BACK FOR EVALUATION. THE UNIT WAS MANUFACTURED IN 2014. END-USER WAS GETTING OFF THE ROLLATOR TO SIT ON A CHAIR. SHE USED ONE SIDE OF THE ROLLATOR TO SUPPORT HERSELF. SHE SHIFTED HER WEIGHT TO THE CHAIR. THE DEVICE'S LEG BROKE AND SHE FELL CUTTING HER LEG ON THE DEVICE. SHE INJURY WOULD NOT STOP BLEEDING. SHE REQUIRED 6 STITCHES. SHE HAD A X-RAY TAKEN IN ER TO CONFIRM NO METAL WAS LODGED IN HER LEG.
Patient problems: Laceration(s)
MAUDE report 11388687 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.