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CHATTANOOGA 1033Recalls & reported problems

Djo, LLC · THERATHERM MOISTHEAT PAD SHLDR · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912000154), received between May 22, 2019 and Nov 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device2
  • Temperature Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 4, 2024Temperature Problem; Temperature Problem

    IT WAS REPORTED THAT IT WAS REPORTED THAT THERE WAS A FIRE DUE TO POSSIBLE MALFUNCTION OF THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20604981 ↗
  • MalfunctionJun 3, 2019Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT "THERATHERM IS OVER HEATING". THERE WAS REPORTEDLY NO INJURY AND THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8662585 ↗
  • MalfunctionMay 22, 2019Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE DEVICE IS OVERHEATING DURING TREATMENT. THERE WAS NO INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8631750 ↗

Other PAD, HEATING, POWERED devices

All PAD, HEATING, POWERED devices →

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