Drive 10216BL-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383265254), received between Jan 29, 2020 and Nov 5, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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

Recent adverse event reports

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

• InjuryNov 5, 2020Off-Label Use; Off-Label Use

  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 DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, A PHOTO WAS PROVIDED. THE END-USER WAS SITTING ON THE DEVICE IN THE KITCHEN. SHE WAS USING HER FEET TO PUSH HERSELF BACKWARDS WHEN THE WHEEL SNAPPED. SHE WAS TRANSPORTED TO THE EMERGENCY ROOM AND DIAGNOSES WITH A BRUISED HIP. SHE HAD NO CAREGIVER SO WAS UNABLE TO RETURN THE UNIT FOR EVALUATION. THE DEVICE IS A ROLLATOR AND INTENDED AS A MOBILITY DEVICE THAT CAN BE USED TO SIT AND REST AS NEEDED. IT IS NOT A TRANSPORTATION DEVICE. THE INSTRUCTIONS FOR USE WARN AGAINST USING THE DEVICE AS A TRANSPORTATION DEVICE. HISTORICAL COMPLAINTS DATA OF THE SAME NATURE WAS VERY LIMITED WITH NO TREND. POSSIBLE ROOT CAUSE FOR THE INCIDENT COULD BE THE USERS BACKWARD MOVEMENT WHILE SITTING USING HER FEET. THIS IS CONSIDERED MISUSE. THIS WILL BE CONSIDERED AN ISOLATED INCIDENT.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 10791533 ↗
• InjuryJan 29, 2020Unintended Movement; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BARIATRIC ROLLATOR. THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. END-USER WAS INJURED WHEN THE ROLLATOR SLID OUT FROM UNDER HIM WHILE HE SAT ON ITS SEAT. THE BRAKES REPORTEDLY FAILED TO WORK WHILE ENGAGED. HE SUFFERED AN L2 VERTEBRAE COMPRESSION FRACTURE REQUIRING SURGICAL REPAIR.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 9643217 ↗