MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08-dec-2021, a spontaneous report was received from the united states via telephone regarding a female (age not reported) who used a thermacare lower back and hip 8hr l/xl heat wrap.Medical history and concomitant products were not provided.On an unspecified date the consumer used a thermacare lower back and hip 8hr l/xl heat wrap (expiration date: 31-jan-2024; lot number: ga0052).On an unspecified date, after using a thermacare lower back and hip 8hr l/xl heat wrap, the consumer experienced burns.It was further stated that she had second degree burns in all areas of the body where she was using it.The consumer noted that she used it as directed.Follow-up attempts have been unsuccessful in establishing contact with the consumer.No additional information was provided.
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 she had " second degree burns in all areas of the body where she was using it".The cause of the consumer stating she had "second degree burns in all areas of the body where she was using it" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.This is an adverse event for second degree burns in all areas of the body where she was using it; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 13180410
• Report Number: 3007593958-2021-00051
• Device Sequence Number: 12124366
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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 Expiration Date: 01/31/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female