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

Lot Number GA0478

Device Problem Insufficient Information (3190)

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

Event Date 12/30/2023

Event Type  Injury  

Event Description

On 31-dec-2023, a spontaneous report from the united states was received via email regarding a 59-year-old female consumer who applied an unspecified thermacare lower back & hip l/xl heat wrap.On 04-jan-2024, additional information was received from the consumer.At 10:00 am on (b)(6) 2023, the consumer topically applied a thermacare lower back & hip l/xl heat wrap to her back for pain.Approximately 10 hours after applying the heat wrap, the consumer removed the heat wrap and experienced a burn with redness where that product was applied.She was in a lot of pain.She attempted to use neosporin for treatment but it did not seem to help.On approximately (b)(6) 2024, the consumer noticed she developed a scab on her back where she was burned.She did not seek medical attention as she would monitor her symptoms from home.As of (b)(6) 2024, her symptoms were ongoing but resolving.No additional information was provided.

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-(b)(4)).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.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 ((b)(4)).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.

• 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; cjhattanooga 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: 18574478
• MDR Text Key: 333662253
• Report Number: 3007593958-2023-00096
• 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: 01/19/2024

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 Operator: Lay User/Patient
• Device Lot Number: GA0478
• Initial Date Manufacturer Received: 12/31/2023
• Initial Date FDA Received: 01/24/2024
• 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
• Treatment: CALCIUM; METOPROLOL; NIFEDIPINE
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female