MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THERMOWRAP¿ UNIVERSAL 135-152CM; THERMAL REGULATING SYSTEM

Model Number	500-03153
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "physical examination reveals deep marks and early-stage skin lesions on the patient's back at the contact areas with the thermal cover, which had been applied according to the guidelines provided during staff training.After repositioning the cover onto the patient's chest, the weight of the water-filled device caused similar marks".
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The thermowrap device involved in this incident has not yet arrived to (b)(6)t for investigation.It was reported there was deep marks and early-stage skin lesions on the patient's back.The user reported this was a nonserious incident and normothermia treatment was suspended to prevent further damage.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.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.Review of batch record was conducted and no issues were noted.No other similar complaints have been reported on the impacted lot of product from any other location.Testing of the actual device will be conducted upon its arrival into belmont.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Additional Manufacturer Narrative
The wrap was requested but not available for investigation.No clinilogger data was available for review, therefore we are unable to determine the water temperature at the time of the event.No images of the alleged skin lesions were available.The reported skin lesions could not be verified, and the root cause could not be determined.No device malfunction was confirmed.The lot history was reviewed, and no similar events were identified.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: THERMOWRAP¿ UNIVERSAL 135-152CM
• 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: 22153684
• Report Number: 1219702-2025-00031
• Device Sequence Number: 9520148
• Product Code: DWJ
• UDI-Device Identifier: 07290012127243
• UDI-Public: 07290012127243
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Device Model Number: 500-03153
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown