MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 01/08/2022

Event Type  Injury  

Event Description

On 13-jan-2022, a spontaneous report from the united states was received from a consumer via telephone regarding an (b)(6) male consumer who was using thermacare heatwraps back pain therapy l-xl 2ct.Medical history included a constant cough, hypertension, high cholesterol, and the consumer was a non-smoker.The consumer had no known allergies.Concomitant products included simvastatin for high cholesterol, an unspecified hypertension medication, and vitamin d.On (b)(6) 2022, the consumer topically applied a thermacare heatwraps back pain therapy l-xl 2ct (lot number: ga0104; expiration date: 31-jul-2024) to his lower back over his underwear for an unspecified indication.After 6 hours of application, the consumer found his skin had a red mark where his underwear was not covering his skin.He noted it was a burn across his lower back waistline.It was 12 inches across and red.The consumer did not express any pain or discomfort, but the reporter noted that he typically wouldn't complain even if any was present.The reporter thought that the his underwear may have shifted while he was wearing the heat wrap which caused direct contact with his skin.The consumer did not perform and did not seek out any treatment options for the events.As of on (b)(6) 2022, the consumer's redness had diminished some.No further 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 " found his skin had a red mark where his underwear was not covering his skin.He noted it was a burn across his lower back waistline".The cause of the consumer stating he had "found his skin had a red mark where his underwear was not covering his skin.He noted it was a burn across his lower back waistline" 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 red mark/ burn; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• 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 ; 4237178579
• MDR Report Key: 13498222
• MDR Text Key: 285698299
• Report Number: 3007593958-2022-00001
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• 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: Other
• Type of Report: Initial
• Report Date: 02/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SIMVASTATIN; UNSPECIFIED HYPERTENSION MEDICATION; VITAMIN D
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 95 KG