MAUDE Adverse Event Report: ANGELINI THERMACARE MUSCLE/JOINT 8HR 3+1CT (BONUS); HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Muscle & Joint

Device Problem Excessive Heating (4030)

Patient Problems Pain (1994); Skin Tears (2516); Partial thickness (Second Degree) Burn (2694)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for a burn and misuse of the product.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2021, a spontaneous report from the united states was received from a consumer regarding a (b)(6) female (ethnicity was not specified) who was using the thermacare muscle/joint 8hr 3 +1 ct(lot number: lcj8289no6/02; expiration date may-2020).The consumer declined to provide medical history and information about usage of any concomitant products.The consumer had used the product for many years without issue.On (b)(6) 2021, the consumer applied one thermacare muscle/joint heat wrap topically to her lower back and then she went to sleep.Six hours later, the consumer woke up to a burning sensation.She immediately removed the product.When she removed the product, she ripped off some skin.She thought the pain was due to the fact that the patch had too much adhesive.However, she had her mother (who is a burn nurse) look at the area and she stated there was a burn at the application site.Initially, no treatment was performed except she put a loose fitting shirt.On (b)(6) 2021, the application site area was painful and a blister had broken open.On (b)(6) 2021, the consumer went to an emergency department and was diagnosed with a second degree burn.For treatment she was given a neosporin mesh as a dressing to protect the area until she had her follow up with her primary medical doctor on (b)(6) 2021.On (b)(6) 2021, the consumer visited her primary care physician and was given oral oxycodone and tramadol for pain control.She was given silvadene (silver sulfadiazine) for treatment of the burn area.She has been having dressings applied to her the area by her mom.She told the doctor about the use of thermacare but the doctor did not tell her why he thought the product would have caused a burn.As of (b)(6) 2021, the consumer's symptoms have not improved but, have not became any worse.She was told that she may need to be referred to a wound care for management, but she has not heard from her provider as to whether they could get her an appointment for assessment.Currently, she does not have any follow up scheduled with her primary care provider.She was upset that the product was still on the market.No additional information was provided.

• Brand Name: THERMACARE MUSCLE/JOINT 8HR 3+1CT (BONUS)
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 1100 market street suite 600; chattanooga TN 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 11703146
• MDR Text Key: 249424252
• Report Number: 3007593958-2021-00004
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733013144
• UDI-Public: 00305733013144
• 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: 04/21/2021

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 Expiration Date: 05/31/2022
• Device Model Number: ThermaCare HeatWraps - Muscle & Joint
• Device Lot Number: LCJ8289NO6/02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 131