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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 31-jan-2026, this spontaneous report was received regarding a 36-year-old female consumer in association with an unspecified thermacare heatwrap.On (b)(6) 2026, the consumer topically applied a thermacare heat wrap to her neck for an unspecified indication.She applied the product and the product did not stick.Subsequently, she secured the product to her neck with tape.After three hours, she removed the product and noted she had a burn mark.The burn was described as having red and black marks that looked like a curling iron touched her skin.She applied vaseline to the affected area and the area was improving.No further information was provided.
Additional Manufacturer Narrative
The consumer stated they used tape to secure the thermacare nsw 8hr product during use.The thermacare labeling and instructions for use provide guidance for the customer to prevent injury during use.The thermacare neck shoulder and wrist 8hr wrap should be applied directly to the neck, shoulder or wrist using the self-adhesive tabs.The product labeling also contains the warning "do not place extra pressure over the product", and the instructions for use are designed to ensure safe and effective usage of the product.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks.The product quality for the batch is not impacted by this complaint.

• Brand Name: THERMACARE HEATWRAP
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: tonya blackwell ; 1231 wyandotte dr; albany, GA 31705 ; 2294463083
• MDR Report Key: 24446166
• Report Number: 3007593958-2026-00006
• Device Sequence Number: 10448549
• 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): 02/13/2026

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: 01/31/2026
• Initial Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 08/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 78 KG