CHATTANOOGA 1032Recalls & reported problems
Djo, LLC · THERATHERM MOIST HEAT 14X27STD · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912000147), received between Oct 24, 2016 and Oct 2, 2019 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (5 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
- Overheating of Device5
- Fire1
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE "DEVICE HEAT JUST KEEPS INCREASING AND WON'T LOWER DOWN. CUSTOMER NOT HURT." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9145374 ↗MalfunctionAug 14, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE HEATING PAD KEEPS HEATING EVEN OVER THE SET UP TEMP. THERE WAS NO REPORTED ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8892400 ↗MalfunctionJul 24, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT "THE UNIT DOES NOT STOP HEATING UP. TEMPERATURE INCREASES TO MAX AND DOES NOT ALLOW USER TO STOP BEFORE THAT." NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8824025 ↗MalfunctionJul 12, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOIST HEAT PACK BURNED THROUGH THE PAD DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8786010 ↗MalfunctionJun 3, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE 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 8662584 ↗MalfunctionOct 24, 2016Fire; Fire
COMPLAINT RECEIVED THAT ALLEGES "HEATING PAD STARTED SPARKING AND CAUGHT FIRE". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED FOR EVALUATION. OEM NOTIFIED OF COMPLAINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6050684 ↗
Other PAD, HEATING, POWERED devices
- HANDY SOLUTIONS HEATING PAD WRAP SHOULDER AND NECK 25607Navajo Manufacturing Company · Pad, Heating, Powered1 recall25 reports
- TearCare(TM) (2.2) System Kit FG 06041Sight Sciences, Inc. · Pad, Heating, Powered1 recall0 reports
- DMI 619-5133-1900D-M-S Holdings, Inc. · Pad, Heating, Powered5 reports
- Sunbeam 053891134019Jarden Consumer Solutions · Pad, Heating, Powered5 reports
- Sunbeam 053891133784Jarden Consumer Solutions · Pad, Heating, Powered5 reports
- Sunbeam 053891174015Jarden Consumer Solutions · Pad, Heating, Powered4 reports
- CONAIR HP15XFConair Corporation · Pad, Heating, Powered3 reports
- CONAIR HP01XFConair Corporation · Pad, Heating, Powered3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.