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

Lot Number	25N339
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
This report was received on 12-mar-2026 regarding a female consumer (age not provided) in association with thermacare neck/shoulder/wrist heat wrap.On an unspecified date, the consumer applied the product and then rested on her recliner.After using the product, she experienced a burn on her skin.The consumer declined talking to medical.She noted that the packaging could be a little clearer for older users.
Additional Manufacturer Narrative
The root cause cannot be identified.There was limited device-specific information provided for this complaint and no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of burn and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection to ensure packaged product quality.There are pre-identified risk factors that could cause a burn/blister 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 conditions, medical conditions, device use error and off-label use.The warning labels on our products are used to address these risk and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 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: 24802144
• Report Number: 3007593958-2026-00012
• Device Sequence Number: 16121923
• 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): 04/07/2026

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
• Device Lot Number: 25N339
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female