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

Lot Number GA0718

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Peeling (1999); Scar Tissue (2060); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

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 a burn.The cause of a burn is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 21-jan-2024, a spontaneous report from the united states was received via email regarding a male (age not provided) who used a thermacare lower back & hip l/xl heat wrap.On an unspecified date, the consumer topically applied a thermacare lower back & hip l/xl heat wrap to his left side for pain.He noted he applied the heat wrap per directions.Approximately, three hours after application the consumer felt an intense burning pain that compelled him to jump out of bed and he strained his back.Upon removing the heat wrap, the consumer observed red raw marks that resembled burns at the area of application.Over the last four days, the sores scabbed over but continued to cause persistent pain.A month later, the scabbed areas developed a scaly appearance leading to irritation.The visible marks resulted in lasting scars.On an unspecified date, he reported the experience with his physician.He noted the burns caused pain and resulted in scarring.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP L/XL
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca anderson ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18704884
• MDR Text Key: 335372245
• Report Number: 3007593958-2024-00006
• 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: 02/12/2024

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 Lot Number: GA0718
• Initial Date Manufacturer Received: 01/21/2024
• Initial Date FDA Received: 02/14/2024
• Date Device Manufactured: 11/14/2022
• 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: Male