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

Lot Number GA0213

Device Problem Excessive Heating (4030)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Pain (1994)

Event Date 01/30/2022

Event Type  Injury  

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 "she felt a burning and pain at the application site.She had red spots that looked like burns.No blisters and no open sores".The cause of the consumer stating she "she felt a burning and pain at the application site.She had red spots that looked like burns.No blisters and no open sores" 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 burns or other skin irritations.This is an adverse event for a burn.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 04-feb-2022, a spontaneous report from the united states was received from a consumer regarding a (b)(6) female who was using a thermcare neck/shoulder/wrist heat wrap.Additional information was received on 07-feb-2022.Medical history included hypertension and high cholesterol.The consumer had no known allergies.Concomitant products included hydrochlorothiazide and lipitor (atorvastatin).On (b)(6) 2022, the consumer topically applied a thermcare neck/shoulder/wrist heat wrap (expiration date: 30-sep-2024; lot number: ga0213) to her neck over her t-shirt.On (b)(6) 2022, approximately 5 minutes after application of the product, she felt a burning and pain at the application site.She took the heat wrap off and it looked red, like it burned her.She had a "pretty bad burn".Her daughter looked at her neck and noted she had red spots that looked like burns.There were no blisters and no open sores.Her daughter wanted her to go to her health care provider but she refused.For treatment she used neosporin and a band-aid.As of (b)(6) 2022, the area looked better but was still red and a little itchy.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST
• 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: 13635492
• MDR Text Key: 286352713
• Report Number: 3007593958-2022-00009
• Device Sequence Number: 1
• Product Code: IMD
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: GA0213
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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: HYDROCHLOROTHIAZIDE; LIPITOR (ATORVASTATIN)
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 75 KG