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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Erythema (1840); Superficial (First Degree) Burn (2685)
Date of Event	01/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 13-jan-2022, a spontaneous report from the united states was received from a consumer via telephone regarding an (b)(6) male consumer who was using thermacare heatwraps back pain therapy l-xl 2ct.Medical history included a constant cough, hypertension, high cholesterol, and the consumer was a non-smoker.The consumer had no known allergies.Concomitant products included simvastatin for high cholesterol, an unspecified hypertension medication, and vitamin d.On (b)(6) 2022, the consumer topically applied a thermacare heatwraps back pain therapy l-xl 2ct (lot number: ga0104; expiration date: 31-jul-2024) to his lower back over his underwear for an unspecified indication.After 6 hours of application, the consumer found his skin had a red mark where his underwear was not covering his skin.He noted it was a burn across his lower back waistline.It was 12 inches across and red.The consumer did not express any pain or discomfort, but the reporter noted that he typically wouldn't complain even if any was present.The reporter thought that the his underwear may have shifted while he was wearing the heat wrap which caused direct contact with his skin.The consumer did not perform and did not seek out any treatment options for the events.As of on (b)(6) 2022, the consumer's redness had diminished some.No further 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 " found his skin had a red mark where his underwear was not covering his skin.He noted it was a burn across his lower back waistline".The cause of the consumer stating he had "found his skin had a red mark where his underwear was not covering his skin.He noted it was a burn across his lower back waistline" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a red mark/ burn; 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: 13498222
• Report Number: 3007593958-2022-00001
• Device Sequence Number: 11956901
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/03/2022

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: 07/31/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SIMVASTATIN; UNSPECIFIED HYPERTENSION MEDICATION; VITAMIN D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 95 KG