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

Lot Number GA0412

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Ulcer (2274)

Event Date 01/13/2024

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 17-jan-2024, a spontaneous report from the united states was received via telephone regarding a 48-year-old female who was using a thermacare lower back and hip heat wrap.On (b)(6) 2024, additional information was received.On (b)(6) 2024, the consumer applied a thermacare lower back and hip heat wrap applied directly to the skin on her lower back.Approximately 7 hours after application, she took the product off.When she took the product off it was painful.She stated when she touched the area, it was wet.When she looked in a mirror, she had 2 round holes where her skin came off that were open.They were about the size of a dime.She experienced her skin peeling and she had a warming sensation.On (b)(6) 2024, she went to urgent care where she was noted to have had a burn.They noted it looked like a chemical burn but did not provide her the degree of burn she experienced.On (b)(6) 2024, the areas were still open.She still had a warming sensation.As of (b)(6) 2024, if she touched the area, it would still sting.She was applying aquaphor for treatment.She anticipated having her next doctor appointment on (b)(6)20245 but did not expect to still issues at that time.

• Brand Name: THERMACARE LOWER BACK & HIP
• 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 ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18575499
• MDR Text Key: 333660010
• Report Number: 3007593958-2024-00003
• 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: 01/24/2024

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: GA0412
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/24/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALLERGY MEDICATION.
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 82 KG