MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP 8 HR HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number LGA0364

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Skin Discoloration (2074)

Event Date 04/11/2023

Event Type  Injury  

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 "her back appeared to have been completely burned.Her skin was black where the heat wrap was".The cause of the consumer stating she received a burn 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 burn; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 18-apr-2023, a spontaneous report from the united states was received via telephone regarding a 70-year-old female consumer who used a thermacare lower back and hip 8hr heat wrap.Approximately on (b)(6)2023 at 8 pm, the consumer applied a thermacare lower back and hip heat wrap for pain.She usually wears the heat wraps over her clothes, but she was in a lot of pain, so she placed it directly on her skin.She then laid down and fell asleep.On (b)(6)2023, 9 hours later (also reported around 1 am) in the morning, she noticed the heat wrap was hot.Her back appeared discolored from what she could see in the mirror.Her skin felt different and continued to feel hot.For treatment she put vaseline on the area.She could not go to the doctor due to the cost.She did not ask her doctor before using the product since it was an over the counter product, although she typically does since she is diabetic and has to be careful with heat.On (b)(6)2023, her sister visited her and took pictures of her back.Her back appeared to have been completely burned.Her skin was black where the heat wrap was.She had a rectangular shape with spots on her back that appeared to be where the heat cells were.As of (b)(6)2023, her skin was warm to the touch, and she had a burning sensation at the area.

• Brand Name: THERMACARE LOWER BACK AND HIP 8 HR HEAT WRAP
• Type of Device: 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: 16906752
• MDR Text Key: 314950122
• Report Number: 3007593958-2023-00026
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2023

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
• Device Operator: Lay User/Patient
• Device Lot Number: LGA0364
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/10/2023
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPERCREME; INSULIN; JANUVIA (SITAGLIPTAN); LIDOCAINE CREAM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female