MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES ALLON; THERMAL REGULATING SYSTEM

Model Number	ALLON 2001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following initial receipt of the user facility's report, belmont's sales representative arranged a call with hospital risk management and learned that cloth towels are inserted between the patient and the wrap, which is not in accordance with the instructions for use.The ifu provides the following warning statement: "warning: ensure that nothing comes between the patient's skin and the thermowrap" and also instructs the user: "when closing the thermowrap around the patient, ensure that it fits loosely.(there should be a finger's width space between the patient and the thermowrap)." belmont medical technologies scheduled a subsequent call with the hospital to obtain additional information about the incident.It was reported that the patient suffered "skin lesions" and not "burns" as initially reported.The serial number of the allon used during the incident was not documented.The hospital's internal testing of all 7 allon units at the facility revealed that none of the devices produced temperatures above 37.6 degrees c.Neither the allon nor the thermowrap involved in the incident has been returned to belmont for investigation, therefore we are unable to confirm whether there are any anomalies with the device.We are aware that there is an ongoing investigation at the hospital and will provide a supplemental report should additional information become available.
Event or Problem Description
Belmont medical technologies received an initial report from the hospital risk management/patient safety officer that the patient potentially sustained burns, limited to the left posterior arm and left hip/upper buttock area, which reportedly developed two days after surgical treatment.

• Brand Name: ALLON
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 12064092
• Report Number: 1219702-2021-00083
• Device Sequence Number: 14396672
• Product Code: DWJ
• UDI-Device Identifier: 07290107581103
• UDI-Public: 7290107581103
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K024128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALLON 2001
• Device Catalogue Number: 200-00263
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1