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CHATTANOOGA FLU115DRecalls & reported problems

Djo, LLC · FLUIDTHERAPY DOUBLE EXTREMITY · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446305149), received between Jul 31, 2019 and Oct 23, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Smoking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Smoking2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 23, 2019Smoking; Smoking

    IT WAS REPORTED THAT THE MACHINE WAS FOUND TO BE SMOKING. THEY MOVED IT OUTSIDE AND COULD NOT GET THE CORN MEDIA TO STOP SMOLDERING SO THEY DUMPED WATER ON IT. THE MACHINE WAS FOUND PLUGGED INTO THE WALL BUT NOT TURNED ON. IT WAS REPORTED TO NOT HAVE BEEN USED THE PRIOR DAY. IT HAD ALLEGEDLY CREATED A LOT OF CORN DUST/PARTICULATE IN THE PREVIOUS MONTHS. THERE WAS NO PATIENT INVOLVEMENT / HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 9226968 ↗
  • MalfunctionJul 31, 2019Smoking; Smoking

    IT WAS REPORTED THAT THE DEVICE WAS "CREATING SMOKE AND BURNING SMELL." NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 8847961 ↗

Other Unit, fluidotherapy devices

All Unit, fluidotherapy devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.