DRIVEMEDICAL K318DFA-SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383133874), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Misassembly by Users” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Misassembly by Users; Misassembly by Users

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT ALLEGEDLY INVOLVING A WHEELCHAIR BY A LETTER FROM AN ATTORNEY, WHICH STATES THE END USER WAS USING THE WHEELCHAIR WITHOUT THE LEGRESTS WHEN HER FOOT CAME INTO CONTACT WITH THE EDGE OF THE FORK ON THE WHEEL, RESULTING IN A LACERATION TO HER FOOT THAT REQUIRED 25 STITCHES. THE END USER WAS PRESCRIBED ANTIBIOTICS. THE END USER WAS LATER ADMITTED TO THE HOSPITAL WITH HEMATOMA TO THE WOUND, WHICH REQUIRED TWO SURGICAL PROCEDURES AND WOUND CARE. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE DEVICE IN COOPERATION WITH THE ATTORNEY.

  Patient problems: Laceration(s)

  MAUDE report 19082199 ↗