MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE MUSCLE/JOINT 8HR; HOT OR COLD DISPOSABLE PACK.

Lot Number GAO432

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Itching Sensation (1943); Peeling (1999); Ulcer (2274)

Event Date 01/15/2024

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 a burn.The cause of the consumer 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 16-jan-2024, a spontaneous report from the united states was received via telephone regarding a 46-year-old female consumer who used a thermacare muscle/joint 8hr heat wrap.On (b)(6) 2024, the consumer applied the heat wrap directly to the skin on her left shoulder for an unspecified indication.After applying the heat wrap, she experienced itching of the application area.After 4 hours of application, the consumer said she pulled the product off without pain.She noted that when she took the heat wrap off some of the top layer of her skin of the back was removed.She looked at her shoulder and saw open circles of pink flesh.It looked like a burn.She had 3 areas which one had a size of a 50-cent piece, another the size of a quarter, and the other one was the size of a nickel.On the morning of (b)(6) 2024, she went to her foot doctor, and she told them about the experience.They did not look at the area but advised her to go to an emergency room (er).She did not go to an emergency room.No further information was provided.

• Brand Name: THERMACARE MUSCLE/JOINT 8HR
• 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 ethride ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18660466
• MDR Text Key: 334776687
• Report Number: 3007593958-2024-00005
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: GAO432
• Date Manufacturer Received: 01/16/2024
• Date Device Manufactured: 05/01/2022
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 68 KG