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

Lot Number LGAO432

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burning Sensation (2146)

Event Date 09/18/2022

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 she " felt a burning sensation to the application area".The cause of the consumer stating she " felt a burning sensation to the application area" 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 burning sensation to the application area; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a female (age not provided) who used a thermacare lower back and hip heat wrap.Medical history and concomitant products were not provided.On (b)(6) 2022, the consumer noted that the boxes of the heat wrap were difficult to open because the glue was so good.She had to completely destroy the box to get to the heat wraps.On (b)(6) 2022, 3 to 4 hours after using the product, she felt a burning sensation to the application area.The heat wrap felt hotter than any other patch she had used.She thought she may have applied it over a thin layer of skin.Subsequently, she moved the patch from her lower back to her upper shoulder area.She felt an intense burning sensation after moving the patch and then it resolved.She felt the patch felt hotter than expected due to her thin skin.She did not think the patch was defective.

• Brand Name: THERMACARE LOWER BACK AND HIP
• 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 ; 4234142221
• MDR Report Key: 15563804
• MDR Text Key: 301364411
• Report Number: 3007593958-2022-00065
• Device Sequence Number: 1
• Product Code: IMD
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: LGAO432
• Date Manufacturer Received: 09/20/2022
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female