DRIVEMEDICAL 12005KDC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383231303), received between Oct 5, 2023 and Oct 5, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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, 2023Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH/COMMODE BY LETTER RECEIVED FROM AN ATTORNEY, WHICH STATED THAT THE END USER "SUSTAINED INJURIES IN AN INCIDENT INVOLVING YOUR UNIT." THE ATTORNEY LATER REPORTED THAT IMMEDIATELY AFTER HAVING ASSEMBLED IT WITH HIS WIFE, "ONE OF THE LEGS FELL OUT" DURING USE, AND CAUSED THE END USER TO SUSTAIN A BONE HEMATOMA, WHICH LATER RESULTED IN AN ABOVE-THE-KNEE AMPUTATION OF HIS LEG. IT WAS REPORTED THAT THE AMPUTATION WAS A SECOND ONE, AND FURTHER INFORMATION REGARDING THE CONDITION THAT LED TO THE PRIOR AMPUTATION(S) WAS NOT PROVIDED. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING COMMUNICATING WITH THE ATTORNEY TO GAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND INSPECT THE PRODUCT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 17877363 ↗