MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07-may-2026, this report was received regarding a 64-year-old male consumer in the us in association with an unspecified thermacare heatwrap.On (b)(6) 2026 at 2000 hours the consumer topically applied a thermacare heat wrap to his lower back.He applied the product directly to the skin on his back and covered it with a shirt.Approximately at 400 am the next morning he experienced pain and took off the product.He noted his skin was burned on the left side of his lower back.He rinsed the area, dried with a paper towel, and applied neosporin.On (b)(6) 2026, he went to his primary care provider and was advised to continue neosporin and not to use the product.As of (b)(6) 2026, the pain and the burn were ongoing.The consumer anticipated having surgery on (b)(6) 2026.No additional information was provided.
Additional Manufacturer Narrative
The most probable root cause is intentional device misuse.The 64-year-old consumer applied the thermacare product directly to the skin from 8:00pm - 4:00am.This complaint did not identify a specific thermacare product variant for the reported incident.The thermacare labeling and instructions for use provide guidance for the customer to prevent injury during use.All thermacare product variants contain the warning "if product feels too hot, stop use or wear over a layer of clothing, not directly against the skin".

• Brand Name: THERMACARE HEAT WRAP
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 1208 king st.; suite 605; chattanooga TN 37403
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: tonya blackwell ; 1231 wyandotte dr; albany, GA 31705 ; 2294463083
• MDR Report Key: 25301846
• Report Number: 3007593958-2026-00023
• Device Sequence Number: 21172652
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/27/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DECLINED TO PROVIDE FURTHER INFORMATION.; MOUNJARO (TIRZEPATIDE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 86 KG