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Drive R728RDRecalls & reported problems

Drive Devilbiss Healthcare · Rollator,7.5" 4Whl.Alum.PadSt,Red,EA · Class 1

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 00822383233253), received between Jul 24, 2018 and Oct 5, 2020 — classified as 2 injuries.

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
  • Solder Joint Fracture1

Patient problems

  • Bone Fracture(s)1
  • Fall1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 5, 2020Material Fragmentation; Material Fragmentation

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE UNIT WAS NEVER RETURNED FOR EVALUATION. THE WHEEL BROKE OFF OF THE DEVICE WHILE IN USE. THE END-USER FELL AND RE-INJURED HIS HIP. THE INCIDENT CAUSED A BRIEF HOSPITAL STAY AND A STINT IN REHAB FOR 5 DAYS. HISTORICAL DATA FOR COMPLAINTS OF THE SAME NATURE WAS REVIEWED AND FOUND TO BE VERY LIMITED REPORTING WITH NO TREND.

    Patient problems: Pain

    MAUDE report 10628074 ↗
  • InjuryJul 24, 2018Solder Joint Fracture; Solder Joint Fracture

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. NOTIFICATION OF THE EVENT WAS EXECUTED THOUGH A THIRD PARTY CLAIMS ADMINISTRATOR OF THE SERVICE PROVIDER. PMS IS ATTEMPTING TO RETRIEVE THE DEVICE FOR EVALUATION. THE END-USER WAS WALKING DOWN A RAMP AT A REST STOP WHEN THE WALKER REPORTEDLY BROKE AND SHE FELL. SHE WAS DIAGNOSED AND TREATED FOR A FRACTURED FEMUR. SHE WAS SENT TO REHAB.

    Patient problems: Bone Fracture(s); Fall

    MAUDE report 7713488 ↗

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.