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Drive 510Recalls & reported problems

Drive Devilbiss Healthcare · Mimi Lite Push Dwn Brake Blue1/cs · 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 00822383108506), received between Dec 9, 2020 and Dec 9, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

Patient problems

  • Fall1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 9, 2020Material Fragmentation; Material Fragmentation

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE WERE UNABLE TO RETRIEVE THE DEVICE FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. UNIT HANDLE BROKE WHILE IN USE. END-USER FELL AND HIT HIS HEAD. HE WAS TAKEN TO THE HOSPITAL. HE DID NOT HAVE ANY BROKEN BONES. HISTORICAL DATA FOR COMPLAINTS OF THE SAME NATURE WERE REVIEWED. VERY LIMITED REPORTING WAS FOUND AND SHOWING NO TREND.

    Patient problems: Fall

    MAUDE report 10977476 ↗

Other WALKER, MECHANICAL devices

All WALKER, MECHANICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.