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Drive RTL10266-TRecalls & reported problems

Drive Devilbiss Healthcare · Nitro Rollator,Tall,Red Frame,1/ea · 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 00822383549484), received between Aug 25, 2021 and Aug 25, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • Fall1
  • Head Injury1

Recent adverse event reports

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

  • InjuryAug 25, 2021Break; Break

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RECEIVED THE DEVICE BACK FOR EVALUATION AS IT HAS BEEN RETURNED TO THE SERVICE PROVIDER. WE WILL FILE A FOLLOW-UP REPORT WHEN ADDITIONAL DATA IS AVAILABLE. THE BRAKE CABLE OF THE DEVICE SNAPPED WHILE IN USE CAUSING THE END-USER TO FALL AND HIT HER HEAD.

    Patient problems: Fall; Head Injury

    MAUDE report 12365760 ↗

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.