MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR 3CT; HOT OR COLD DISPOSABLE PACK

Model Number	ThermaCare HeatWraps - Neck, Wrist & Shoulder
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause can not 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 " when she removed the product, she noticed her neck was red, burning, and hot to the touch." the cause of the consumer noticing "when she removed the product, she noticed her neck was red, burning, and hot to the touch." 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, red, and hot to touch; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 24-jun-2021 a spontaneous report was received from a consumer regarding a (b)(6) year-old female consumer who was using thermacare neck/shoulder/wrist 8hr 3ct heat wrap.The consumer had no known allergies and was reported to be healthy.Concomitant products included tylenol (acetaminophen).Approximately on (b)(6) 2020 at 8am, the consumer topically applied one thermacare neck/shoulder/wrist 8hr heat wrap (lot: ek9154, expiration date: 31-mar-2024) to the back of her neck on her skin for an unspecified indication.The consumer did not remove the heat wrap until 10 pm the same day, when she took a shower.When she removed the product, she noticed her neck was red, burning, and hot to the touch.She was not 100% clear was when she discovered her symptoms.After her shower she looked into the mirror and saw the redness.The redness was the same size as the product.On (b)(6) 2021, she applied aloe vera gel to the area which reduced the redness by the next day.All of her symptoms resolved within a couple of days.She did not seek medical attention and did not seek or attempt any other treatments.She only used one of the heat wraps in the box.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR 3CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12174030
• Report Number: 3007593958-2021-00024
• Device Sequence Number: 13826144
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Device Lot Number: EK9154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 64