MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR S/M; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0364

Device Problem Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694); Skin Infection (4544)

Event Date 12/04/2022

Event Type  malfunction  

Event Description

On 05-dec-2022, a spontaneous report from the united states was received via email regarding a 54-year-old female consumer.Medical history was not provided, except it was noted that she used thermacare previously without issue.She had no known drug allergies.Concomitant products were not provided.On (b)(6) 2022, the consumer topically applied a thermacare lower back 8hr small and medium heat wrap to her lower back.On (b)(6) 2022, additional information was received from the consumer.After applying the heat wrap, she noticed a burning sensation and felt that the heat wrap heated up more than expected.After approximately four to five hours, she removed the heat wrap and noticed a pink spot that resembled a sunburn.It was the size of half of the patch on the area of the application.She attempted to apply triple antibiotic to alleviate the burning sensation, but it did not resolve it.She believed that her clothes rubbing against the area aggravated the irritation.On (b)(6) 2022, it was learned that she did not seek medical attention.She kept using the triple antibiotic and she also used a burn cream that she purchased at the store.She declined to provide the name of the burn cream.The cream and the triple antibiotic helped some but only for a short time, and her symptoms were still present.It was clarified that she still had a burning sensation.She also still had red and irritated skin from where the top layer of skin burned off.Her clothing still made her symptoms more irritated.No additional information was provided.

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 she "had red and irritated skin from where the top layer of skin burned off" after wearing a wrap".The cause of the consumer stating she received skin irritation and a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a burn and skin irritation; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR S/M
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4234142221
• MDR Report Key: 15997471
• MDR Text Key: 308251237
• Report Number: 3007593958-2022-00089
• 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: 12/15/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: GA0364
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/16/2022
• Date Device Manufactured: 03/02/2022
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 84 KG