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
- Drive 10257BL-1Drive Devilbiss Healthcare · WALKER, MECHANICAL13 reports
- Drive R726RDDrive Devilbiss Healthcare · WALKER, MECHANICAL1 death10 reports
- Drive 790Drive Devilbiss Healthcare · WALKER, MECHANICAL10 reports
- Drive 10257RD-1Drive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive R726BKDrive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive R728BLDrive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- DRIVEMEDICAL 795BDrive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive RTL10266Drive Devilbiss Healthcare · WALKER, MECHANICAL8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.