DRIVEMEDICAL 795BKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383213491), received between Jul 25, 2019 and Apr 28, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT THE "SEAT COLLAPSED, AND HE FELL AND INJURED HIS BACK." THE END USER DID NOT SEEK ANY MEDICAL TREATMENT AS A RESULT OF THE INCIDENT, BUT HE REPORTS THAT HE IS STILL FEELING PAIN AND TAKING IBUPROFEN. 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: Fall

  MAUDE report 16837291 ↗
• InjuryOct 30, 2020Device Tipped Over; Device Unsafe to Use in Environment; Device Tipped Over; Device Unsafe to Use in Environment

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE WAS NOT RETURNED FOR EVALUATION SINCE IT WAS NOT A DEVICE ISSUE. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. END-USER WAS AT INDY 500 SITTING ON THE ROLLATOR WHILE BEING PUSHED AROUND. ROLLATOR HIT A BUMP AND OCCUPANT FELL FORWARD. HE HIT HIS HEAD SUFFERING A CUT AND A BRUISE. EMTS CHECKED HIM AND HE WAS CLEARED. NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE DEVICE WAS NOT RETURNED AS IT WAS NOT DAMAGED. END-USER STATED THAT HE USED THE DEVICE AS A TRANSPORT CHAIR ON OTHER OCCASIONS WHERE IT TIPPED FORWARD AND HE SUFFERED NO INJURIES. IFU PRECAUTIONS NOTE THAT SEAT SHOULD NOT BE USED ON INCLINE OR UNEVEN GROUND.

  Patient problems: Bruise/Contusion; Fall; Laceration(s)

  MAUDE report 10762013 ↗
• InjuryJul 25, 2019Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE WERE NOTIFIED OF THE INCIDENT BY A LETTER WRITTEN BY THE END-USER'S SPOUSE. WE DO NOT EXPECT RETURN OF THE DEVICE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. THE USER WAS ONA CEMENT PATH IN THE PARK WHEN THEY TRANSITIONED THE ROLLATOR INTO A TRANSPORT CHAIR BY TURNING THE BACKREST AROUND, AND PULLING OUT THE FOOT REST. HE SAT DOWN AND THE CAREGIVER STARTED TO PUSH HIM. AT A CRACK IN THE SIDEWALK THE WHEELS LOCKED. THE USER WAS THROWN OFF THE SEAT AND ONTO THE CEMENT, FACE FIRST. HE SUFFERED A BROKEN NOSE, 2 BLACK EYES, CUTS UNDER HIS EYES, MANY BRUISES AND LACERATIONS, AND A HIT ON THE HEAD. HE WAS TAKEN BY THE EMS TO THE HOSPITAL WHERE HE WAS TREATED FOR LACERATIONS AND A BROKEN NOSE. HE REMAINED OVERNIGHT. INSTRUCTIONS CLEARLY STATE TO "DO NOT USE SEAT WHEN UNIT IS ON INCLINE OR UNEVEN GROUND."

  Patient problems: Fracture, Arm; Laceration(s)

  MAUDE report 8828874 ↗