DRIVEMEDICAL 12011KDC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383231129), received between Oct 5, 2023 and Oct 5, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• InjuryOct 5, 2023Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH BY SERVICE OF A LAWSUIT. THE LAWSUIT ALLEGES THAT WHILE THE PATIENT WAS USING THE TRANSFER BENCH, THE LEG BROKE, CAUSING HIM TO FALL BACKWARDS AND HIS NECK TO MOVE FORWARD. THE END USER ALLEGES THAT A MYRIAD OF SERIOUS INJURIES, INCLUDING QUADRIPLEGIA, RESULTED FROM THE ACCIDENT, BUT INFORMATION UNCOVERED DURING THE LAWSUIT HAS SUGGESTED THAT HE WAS ALREADY QUADRIPLEGIC AND USING A WHEELCHAIR PRIOR TO THE ACCIDENT. DRIVE IS DEFENDING THE LAWSUIT AND IS LIMITED TO THE INVESTIGATION POSSIBLE THROUGH THE LAWSUIT.

  Patient problems: Fall; Head Injury; Neck Pain

  MAUDE report 17879577 ↗