DRIVEMEDICAL CX416ADFA-ELRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383528311), received between May 1, 2023 and Oct 23, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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 18, 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.

• MalfunctionOct 23, 2023Sharp Edges; Sharp Edges

  WE RECEIVED THE EMAIL FROM OUR CUSTOMER DRIVE, THE DETAILS AS BELOW: MEDWATCH REPORT # 2438477-2023-00105. THE MEDICAL DEVICE INVOLVED IN THE INCIDENT IS A WHEELCHAIR, PRODUCT CODE: IOR, MODEL NUMBER DFL19-BL. THE SERIAL NUMBER IS UNKNOWN. PLEASE REFER TO THE MEDWATCH REPORT FOR INFORMATION ABOUT THE EVENT. AS OF TODAY, THE PRODUCT IN QUESTION HAS NOT BEEN RETURNED TO DRIVE MEDICAL FOR EVALUATION. DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY AN END USER'S CARETAKER, WHO STATED THAT THE END USER WAS TRANSFERRING OUT OF THE CHAIR AND SUSTAINED A "SIGNIFICANT LEG INJURY" AND THAT "IT IS POSSIBLE THIS WAS CAUSED BY A SHARP EDGE ON THE FRAME OF THE WHEELCHAIR." THE END USER WAS PROVIDED WITH WOUND CARE AND PAIN MEDICINE AS A RESULT OF THE INCIDENT. 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: Laceration(s)

  MAUDE report 17993011 ↗
• InjuryMay 1, 2023Sharp Edges; Sharp Edges

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY AN END USER'S CARETAKER, WHO STATED THAT THE END USER WAS TRANSFERRING OUT OF THE CHAIR AND SUSTAINED A "SIGNIFICANT LEG INJURY" AND THAT "IT IS POSSIBLE THIS WAS CAUSED BY A SHARP EDGE ON THE FRAME OF THE WHEELCHAIR." THE END USER WAS PROVIDED WITH WOUND CARE AND PAIN MEDICINE AS A RESULT OF THE INCIDENT. 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: Laceration(s)

  MAUDE report 16846371 ↗