THERMOPHORE 055

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-06 for THERMOPHORE 055 manufactured by Battle Creek Equipment.

Event Text Entries

[182365469] Customer stated, "she smelled smoke and felt the pad was very hot. She released the lever and the pad was still getting hotter. She saw the embers under the cover and grabbed the pad and jumped up then the pad burst into flames. She took the pad out side, threw it and went and got a bucket of water and doused the pad, putting the fire out. " customer did not claim injury. Product was not returned. Lot code information was not provided. An investigation into similar feedbacks for fire found that the primary cause of similar reported issues were caused by customer misusing the product by laying on/ folding the pad while in use. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds". The investigation is inconclusive without the returned product. Further determination into the root cause of the issue will be conducted when device or additional information is obtained. Updated: product was returned on 1/10/2020 and investigated on 1/14/2020. The investigator observed that upon return the pad had a burned hole in the unit. The investigator observed evidence that the pad was being folded/ laid upon. The investigator determined that this misuse of folding / laying on the unit caused a hot spot which caused the unit to light on fire. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1832415-2020-10995
• MDR Report Key: 9677717
• Report Source: CONSUMER
• Date Received: 2020-02-06
• Date Added to Maude: 2020-02-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL GREEN
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERMOPHORE
• Generic Name: THERMOPHORE
• Product Code: IRT
• Date Received: 2020-02-06
• Returned To Mfg: 2020-01-10
• Model Number: 055
• Lot Number: 055 4810
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BATTLE CREEK EQUIPMENT
• Manufacturer Address: 702 S REED RD FREMONT IN 46737 US 46737

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-06