Hugo 700-959E (UDI 07540212106020)Recalls & reported problems
Drive Devilbiss Healthcare · Hugo Elite eCom Edition, 1 EA,Brown Box · 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 07540212106020), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Bruise/Contusion1
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT "THE RIGHT-HAND GRIP SLIPPED OFF AND CAUSED A FALL," SUSTAINING BRUISING ON HIS BACK. HE WAS TAKEN TO THE HOSPITAL FOR EVALUATION AND WAS TREATED WITH PAIN RELIEF MEDICATION. 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: Bruise/Contusion; Fall
MAUDE report 15995369 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.