MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR; HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Neck, Wrist & Shoulder

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 09/06/2022

Event Type  Injury  

Event Description

On 06-sep-2022, a spontaneous report from the united states was received via telephone regarding a 66-year-old female who used a thermacare neck/shoulder/wrist 8hr heat wrap.Medical history included high cholesterol.Allergies included sodium pentothal, sulfonamides, penicillin, and swordfish.Concomitant products included an unspecified medication for high cholesterol.On (b)(6) 2022, the consumer applied a thermacare neck/shoulder/wrist 8hr heat wrap directly to her skin on her left thigh.She wore loose fitting jogging pants over the heat wrap.Approximately 4 hours after application, the heat wrap started to fall off.The edges were peeled back and were no longer sticking to her skin.She was at a store and went to the bathroom to see if she could help make it stick.She removed her clothing and noted skin redness at the application site.She noted the heat wrap burned her in 3 different places.The redness was in the shape of the heat wrap and was only at the application site.She denied pain or discomfort.After she saw the redness, she did not feel comfortable in trying to get the heat wrap to stick.She threw the patch away and went home.Once she arrived at home, she applied ice to the area and aloe vera.She did not go to the hospital because she thought they would just tell her as of (b)(6) 2022, the redness was gradually fading and was pink in color.She did not have any pain, blisters, or open areas.

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 "heat wrap burned her in 3 different places".The cause of the consumer stating "heat wrap burned her in 3 different places" 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; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR
• 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: 15481876
• MDR Text Key: 300582814
• Report Number: 3007593958-2022-00060
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Device Lot Number: GA0354
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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: UNSPECIFIED MEDICATION FOR HIGH CHOLESTEROL
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 61 KG