MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK & HIP; HOT OR COLD DISPOSABLE PACK.

Lot Number	GA1822
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 09-apr-2026, this spontaneous report was received from the united states regarding a female consumer (age not provided) in association with a thermacare lower back and hip heat wrap.On an unspecified date, the consumer noted that bottom and middle sections of the heat wrap were underfilled.The substance started leaking out causing moisture of some type.She had visible moisture on her back coming from the pad.Follow up attempts were unsuccessful.No additional information was provided.
Additional Manufacturer Narrative
Investigation findings and conclusion are pending completion of the investigation as the retain samples have confirmed the reported defect (heat cells damaged/leaking).This is a product quality complaint for heat cells damaged/leaking.Evaluation of the retain samples shows insufficiently filled heat cells and stray chemistry premix outside of the cells.The review of the device history record, batch thermal records, and production controls met the product release criteria.There are pre-identified risk factors that could cause heat cell contents to leak listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.There are material and product defect risks identified and mitigated to reduce the risk of these defects.In addition to these hazards, there are risks that are outside the control of the site, which include things like user-damaged cells upon opening (e.G., using scissors).The product warning labels instruct the consumer not to use the product "if heat cell contents leak and/or wrap is damaged or torn.".

• Brand Name: THERMACARE LOWER BACK & HIP
• 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: 25033291
• Report Number: 3007593958-2026-00019
• Device Sequence Number: 21062848
• 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,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: GA1822
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 09/01/2025
• 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 Sex: Female