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

Lot Number GA0936

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2024

Event Type  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 the wrap became too hot.The cause of the consumer stating the wrap became too hot is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a wrap to be too hot 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.

Event Description

On (b)(6) 2024, a spontaneous report from the united states was received vis telephone regarding a 45-year-old male who used a thermacare lower back and hip l/xl heat wrap.On approximately on (b)(6) 2024, the consumer topically applied a thermacare lower back and hip l/xl heat wrap for an unspecified indication.On an unspecified time after application of the product, the consumer removed the product because it became too hot.No injury was reported.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 ethridge ; 1231 wyandotte dr; atlanta, GA 31705 ; 2294463085
• MDR Report Key: 19072748
• MDR Text Key: 339995948
• Report Number: 3007593958-2024-00021
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: GA0936
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• Date Device Manufactured: 06/01/2022
• 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: 45 YR
• Patient Sex: Male