THERMOPHORE 155

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 2020-02-11 for THERMOPHORE 155 manufactured by Battle Creek Equipment.

Event Text Entries

[182722336] Customer stated, " the pad caught fire by the wires leading into the switch. " customer did not claim injury. Product was not returned. An investigation into the manufactured lot found no other instances of potential fires occurring from this lot. An investigation into returned products for pad fire found that fire was primarily caused by customer misuse of twisting/ wrapping the cord to tight or folding/ laying on the pad. The ifu states, "loop cord loosely when storing. Tight wrapping may damage cord and internal parts. ", "do not sit on, lie on, or crush pad. Avoid sharp folds". Further investigation will be conducted once the product is returned, along with a supplemental report submitted. Updated: product was returned 1/28/2020 and investigated on 1/29/2020. The investigator observed evidence of fire/ burn cut on the cord. Additionally the investigator observed that the cord was twisted. The investigator determined that the twisting of the cord lead to a breaking of the casing by the switch, which then caused the customers reported event. The ifu states, "loop cord loosely when storing. Tight wrapping may damage cord and internal parts. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1832415-2020-11020
• MDR Report Key: 9696204
• Report Source: CONSUMER
• Date Received: 2020-02-11
• Date Added to Maude: 2020-02-11
• 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: 2020-02-11
• Returned To Mfg: 2020-01-28
• Model Number: 155
• Lot Number: 00155065195
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BATTLE CREEK EQUIPMENT
• Manufacturer Address: 702 S REED RD FREMONT, IN US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-11