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DMI 802-2014-2100Recalls & reported problems

D-M-S Holdings, Inc. · 3-Wheel Aluminum Rollator Royal Blue · 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 00041298003571), received between May 28, 2026 and May 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of or Failure to Bond1

Patient problems

  • Fall1
  • Limb Fracture1
  • Limb Pain1

Recent adverse event reports

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

  • InjuryMay 28, 2026Loss of or Failure to Bond

    USER REPORTED - THE FRONT WHEEL FELL OFF, I HAD THE HANDLEBARS IN MY HAND AND THE WALKER WENT DOWN. MY HANDS WENT DOWN WITH IT AND MY FOOT GOT FRACTURED.

    Patient problems: Fall; Limb Fracture; Limb Pain

    MAUDE report 25319698 ↗

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.