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

Lot Number	GA1262 6-22-2024
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 01-may-2025, a spontaneous report was received from the united states via email regarding a female (age not provided) who used a thermacare neck/shoulder/wrist 8 hr heat wrap.On 01-may-2025, the consumer topically applied a thermacare neck/shoulder/wrist 8 hr heat wrap.One hour after wearing the product she removed the product.She noted that the product burned her skin and caused discomfort.She noted that the product was too small for her.The consumer declined to provide further information.
Additional Manufacturer Narrative
The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports a burn.The cause of the consumer receiving a burn is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST HEAT WRAP
• 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: 22113893
• Report Number: 3007593958-2025-00019
• Device Sequence Number: 20004832
• 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): 05/30/2025

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
• Device Lot Number: GA1262 6-22-2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 06/01/2024
• 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 Sex: Female