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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	11/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During site visit, belmont's clinical specialist was informed that the patient suffered a burn during use with an allon unit.
Additional Manufacturer Narrative
The internal complaint file # cmp-(b)(4) has been logged for this incident for traceability.The device involved in this incident has not been returned to belmont for investigation.It was reported that there was a thermal injury to the patient while being treated with allon, but there is no evidence that the device caused injury or any details to the extent of this reported injury at this time.The circulating water temperature in the allon is limited by software to 40.8 c and by hardware to 42 c and is not expected to cause skin breakdown.A picture was provided that indicates a blister which the user indicated as 2 x1 cm in size.The operator's manual provides the following warning statement: " the user should verify that no fluids are present at the skin/wrap interface during the procedure.Failure to do so can cause lesions on the patient's skin.Following the procedure, a pattern resembling the wrap may appear for a short period of time on the patient's skin".Pressure sores may appear or develop when soft tissue is compressed between a bony prominence and external surface.The use of the allon® system does not prevent this from happening.In order to prevent pressure sores, hospital routine care should be taken during long thermoregulation procedures thermowrap involved in this incident was not sent to belmont for investigation therefore, a thorough investigation into the wrap involved could not be carried out.The user facility sent us the picture showing how they wrap the patients using thermowrap and we noticed that there is a fold in the arms while wrapping the patient.Belmont is evaluating to see if this fold could cause any kind of thermal injury to the patient.We are working with our medical advisor to get his input on this incident and are attempting to obtain further information from the user facility.A follow-up report will be submitted once the additional information becomes available.
Additional Manufacturer Narrative
It was determined that none of the wraps involved were saved for investigation.No clinilogger data was available for investigation, therefore we are unable to determine the water temperature at the time of the treatment.Images of the reported burns were reviewed by a belmont clinical specialist.From the reviewed images, it cannot be conclusively determined if these marks were thermal burns, chemical burns, pressure injuries, or a combination of two or more sources.It could not be determined which device(s) were in use on the patients the experienced the reported burns.A belmont service technician went onsite to test all the allon units.After review, there were no issues found that would have contributed to the reported burns.All devices were system tested and passed with no issues.No device malfunction could be verified.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: ALLON®
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 21071609
• Report Number: 1219702-2025-00001
• Device Sequence Number: 20909696
• Product Code: DWJ
• UDI-Device Identifier: 07290107581103
• UDI-Public: 07290107581103
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown