Drive 10210-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00822383117379), received between Jul 24, 2019 and Jul 21, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A WALKER BY AN END USER, WHO STATED THAT "HE WAS WALKING FROM HIS BATHROOM TO HIS BED AND THE LEFT REAR LEG SNAPPED" AND HE REPORTEDLY FELL AND SUSTAINED BRUISING AND PAIN NEAR HIS LOWER BACK. THE END USER CONFIRMED THAT THERE WAS NO MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. 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: Bruise/Contusion; Fall

  MAUDE report 17370552 ↗
• InjuryMay 16, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A WALKER BY AN END USER'S SON, WHO STATED THAT "THE LOCKING SYSTEM FAILED, RESULTING IN COLLAPSE OF WALKER AND INDIVIDUAL USING IT." THERE WAS NO INJURY REPORTED WITH THE INITIAL COMPLAINT, BUT IT WAS LATER REPORTED THAT THE END USER WAS HOSPITALIZED FOLLOWING THE INCIDENT, ALTHOUGH IT IS UNCLEAR WHETHER THE HOSPITALIZATION RESULTED FROM THE INCIDENT OR OTHER UNRELATED CONDITIONS. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943086 ↗
• InjurySep 24, 2022Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT WHILE USING THE DEVICE, SHE FELL OVER THE TOP OF IT WHEN "THE RIGHT SIDE OF THE WALKER WHERE HER RIGHT HAND GOES, THE BAR BELOW THAT CAME APART." THE END USER FRACTURED HER HIP. 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: Bone Fracture(s); Fall

  MAUDE report 15476300 ↗
• InjurySep 6, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A WALKER FROM AN END USER, WHO REPORTED THAT WHILE RECOVERING FROM SPINAL SURGERY, HE WAS "USING THE WALKER WHEN THE BACK RIGHT LEG BENT AND COLLAPSED AND HURT HIS NECK AND HIS BACK AND WILL BE SEEKING MEDICAL ATTENTION AT HIS NEXT DOCTOR'S APPOINTMENT." DRIVE HAS ATTEMPTED TO CONTACT THE END USER TO GATHER ADDITIONAL INFORMATION AND RETRIEVE THE PRODUCT FOR EVALUATION, BUT THERE HAS BEEN NO RESPONSE. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Neck Pain; Pain

  MAUDE report 15363253 ↗
• InjuryJul 11, 2022Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT WHILE USING THE DEVICE, SHE FELL OVER THE TOP OF IT WHEN "THE RIGHT SIDE OF THE WALKER WHERE HER RIGHT HAND GOES, THE BAR BELOW THAT CAME APART." THE END USER FRACTURED HER HIP. 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: Bone Fracture(s); Fall

  MAUDE report 14976473 ↗
• InjuryNov 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WALKER. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE UNIT WAS DISPOSED OF PRIOR TO EVALUATION. THE BACK LEG BENT WHILE IN USE. THE END-USER FELL AND HIT HER KNEE AND HEAD. SHE WENT TOT HE DOCTOR THE NEXT DAY. NO SERIOUS INJURY WAS SUSTAINED. HISTORICAL DATA OF COMPLAINTS OF THIS NATURE WAS REVIEWED AND FOUND VERY LIMITED WITH NO TREND AND A (B)(4) PERCENT DEFECT RATE OVER THE PRIOR TWO YEARS. ROOT CAUSE CANNOT BE DETERMINED AS THE UNIT WAS DISCARDED.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 10886080 ↗
• InjuryJul 24, 2019Fracture; Fracture

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. REPORT OF THE INCIDENT ORIGINATED FROM SERVICE PROVIDER. THE INITIAL REPORTER HAS PASSED OFF THE TASK TO ANOTHER STAFF MEMBER. PICTURES WERE PROVIDED. WE STILL HAVE NOT OBTAINED THE UNIT FOR EVALUATION. WHEN ATTEMPTING TO STAND THE WALKER BROKE CAUSING THE PATIENT TO FALL. THE PATIENT WAS READMITTED TO THE HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Fall

  MAUDE report 8823387 ↗