MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK AND HIP; HOT OR COLD DISPOSIBLE PACK

Lot Number	GA1644
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Itching Sensation (1943); Fluid Discharge (2686)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received on 18-may-2026, via telephone, from a 62-year-old, nonsmoking, female consumer in the us in association with thermacare lower back and hip heat wrap.Follow up was completed with the consumer on (b)(6) 2026 via telephone.All contacts will be treated as an initial report.The consumer used thermacare lower back and hips heat wrap on (b)(6) 2026, by placing it on her upper arm/elbow, at around 2200.She put her night sweater over the thermacare, fell asleep and woke up at 0700.The consumer experienced itching and removed the wrap, and experienced skin peeling, burning sensation, redness and oozing.She applied triple antibiotic ointment.On (b)(6) 2026, the consumer saw her doctor for ongoing symptoms and was diagnosed with a burn.She was given silver sulfadiazine 1 mg cream for treatment and told to follow-up if symptoms persist over 14 days.The area was healing but taking longer than expected.The oozing resolved on approximately on (b)(6) 2026.She had a mild stinging sensation on the area.No additional information was provided.
Additional Manufacturer Narrative
The most probable root cause for the reported adverse event is intentional device misuse.In this case the consumer applied the thermacare lower back and hip (lbh) product on the elbow.The hazard analysis (b)(4) classifies this type of complaint as a use error - application in wrong location.The potential harm is reduced therapeutic benefit or possible skin burn.The warning labels on the thermacare product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.The lbh heatwrap is designed specifically for the lower back and hip area.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 related to this complaint.The product quality for the batch is not impacted by this complaint.

• Brand Name: THERMACARE LOWER BACK AND HIP
• Common Device Name: HOT OR COLD DISPOSIBLE PACK
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 1208 king st.; suite 605; chattanooga TN 37403
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany TN 31705
• Manufacturer Contact: tonya ; 1231 wyandotte dr; albany, GA 31705 ; 2294463083
• MDR Report Key: 25470200
• Report Number: 3007593958-2026-00028
• Device Sequence Number: 21439119
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: GA1644
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AN UNSPECIFIED PAIN MEDICATION FOR ARTHRITIS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female