Drive R726BKRecalls & reported problems
Drive Devilbiss Healthcare · Rollator,6in 4Whl.Alum.PaddedSt,Blk,1/cs · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00822383240664), received between Nov 10, 2021 and Dec 11, 2024 — classified as 8 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (4 reports).
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
Most reported problems
Device problems
- Mechanical Problem4
- Break2
- Sharp Edges2
- Appropriate Device Problem Term/Code Not Available1
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)3
- Laceration(s)3
- Fall2
- Abrasion1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2024Mechanical Problem; Mechanical Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR ALLEGING THE END USER RECEIVED A LACERATION BY THE EXPOSED BRAKING MECHANISM. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Patient problems: Laceration(s)
MAUDE report 20904292 ↗InjuryApr 30, 2024Sharp Edges; Sharp Edges
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE END USER INVOLVING A ROLLATOR WHERE THE END USER LOST HIS BALANCE, FELL ONTO THE ROLLATOR, AND SUSTAINED A LARGE LACERATION ON HIS LEG DUE TO THE BRAKE ASSEMBLY. HE RECEIVED 27 STAPLES ON THE LACERATION. DRIVE DEVILBISS HEALTHCARE IS REQUESTING THE RETURN OF THE DEVICE FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Laceration(s)
MAUDE report 19217488 ↗InjuryDec 2, 2023Mechanical Problem; Mechanical Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO REPORTED THAT THE FRONT WHEELS CONTINUED TO MOVE WHILE THE BRAKES WERE LOCKED. THE END USER DID NOT FALL, BUT REPORTED THAT BECAUSE SHE CONTINUED TO HOLD ONTO THE ROLLATOR WHEN IT WAS MOVING, SHE EXPERIENCED A SHARP PAIN IN HER PREVIOUSLY REPLACED ELBOW AND WAS DIAGNOSED WITH A COMPLEX FRACTURE AND REFERRED TO AN ELBOW SPECIALIST. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, HOWEVER THE END USER REFUSED TO RETURN THE DEVICE FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 18253281 ↗InjuryNov 29, 2023Mechanical Problem; Mechanical Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO REPORTED THAT THE FRONT WHEELS CONTINUED TO MOVE WHILE THE BRAKES WERE LOCKED. THE END USER DID NOT FALL, BUT REPORTED THAT BECAUSE SHE CONTINUED TO HOLD ONTO THE ROLLATOR WHEN IT WAS MOVING, SHE EXPERIENCED A SHARP PAIN IN HER PREVIOUSLY REPLACED ELBOW AND WAS DIAGNOSED WITH A COMPLEX FRACTURE AND REFERRED TO AN ELBOW SPECIALIST. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, HOWEVER THE END USER REFUSED TO RETURN THE DEVICE FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 18230791 ↗InjuryOct 19, 2023Mechanical Problem; Mechanical Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT THE BRAKES FAILED, REPORTEDLY CAUSING HER TO FALL AND BREAK HER ANKLE. THE END USER DID NOT PROVIDE ANY INFORMATION REGARDING MEDICAL TREATMENT. REPEATED ATTEMPTS TO GATHER ADDITIONAL INFORMATION AND TO HAVE THE DEVICE RETURNED FOR INVESTIGATION WERE UNSUCCESSFUL. IF PERTINENT INFORMATION BECOMES AVAILABLE, DRIVE WILL FILE AN ADDENDUM TO THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 17968512 ↗MalfunctionMay 9, 2023Break; Break
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER WHO STATED, "THE BACKREST BRACKET BROKE SENDING HIM TO THE FLOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. ATTEMPTS WERE MADE TO RETRIEVE THE PRODUCT FOR INVESTIGATION. THE END USER IS UNABLE TO RETURN THE UNIT FOR INVESTIGATION AND DOESN'T HAVE ANYONE WHO CAN ASSIST HIM. A FULL REPLACEMENT WAS SENT TO THE END USER. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.
Patient problems: Fall
MAUDE report 16900307 ↗InjuryMay 3, 2023Break; Break
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER WHO STATED, "THE BACKREST BRACKET BROKE SENDING HIM TO THE FLOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. ATTEMPTS WERE MADE TO RETRIEVE THE PRODUCT FOR INVESTIGATION. THE END USER IS UNABLE TO RETURN THE UNIT FOR INVESTIGATION AND DOESN'T HAVE ANYONE WHO CAN ASSIST HIM. A FULL REPLACEMENT WAS SENT TO THE END USER. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.
Patient problems: Fall
MAUDE report 16864812 ↗InjuryJul 19, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER STATED THAT SHE WAS SITTING IN HER ROLLATOR, SWUNG HER LEG AROUND, AND THE BRAKE ASSEMBLY CUT HER LEG. SHE SOUGHT MEDICAL ATTENTION AND RECEIVED ONGOING WOUND CARE. 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: Abrasion
MAUDE report 15053587 ↗InjuryNov 10, 2021Sharp Edges; Sharp Edges
(B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE USER IS REFUSING TO RETURN THE DEVICE. WE WILL FILE A FOLLOW-UP SUBMISSION IF ADDITIONAL DATA BECOMES AVAILABLE. THE END USER REPORTED THAT THERE ARE SHARP EDGES ON HER DEVICE. A CHILD FELL INTO THE DEVICE AND RECEIVED A LACERATION ON THEIR HEAD WHICH REQUIRED 5 STITCHES .SHE IS CONCERNED ABOUT THE SHARPNESS SINCE SHE IS ON BLOOD THINNERS.
Patient problems: Laceration(s)
MAUDE report 12791790 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.