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	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On 24-mar-2021, a spontaneous report was received via telephone from a consumer regarding a (b)(6)-year old female (ethnicity not reported) who was using thermacare neck/shoulder/wrist 8 hr 3ct (lot number: lef0574; expiration date: jul-2023).Medical history included 4 prior eye operations, poor eyesight, asthma with usage of a rescue inhaler, sciatica pain, neck herniations, a neck surgery, and hypertension.Concomitant products included an unspecified asthma rescue inhaler and unspecified medications for hypertension.The reporter declined to provide further details regarding medical history and about concomitant products.On (b)(6) 2021, the consumer topically applied the thermacare neck/shoulder/wrist 8 hr 3ct to her lower right buttock and upper right thigh for sciatica pain.She applied the product directly to her skin.She applied the product during the day (on (b)(6) 2021) for 8 hours and then she went to bed.Approximately 8 hours after going to bed (she wore the product for 16 hours total), she woke up with an extreme burning sensation at the application site.When she removed the product, she found a burn at the application site that looked like red streaks and circles that were consistent with the 'holes' in the patch.The 'holes' were clarified as she meant that her burns lined up with the heating agents on the product.She also observed blisters.For treatment, she applied aquaphor to the area.On the morning of (b)(6) 2021, she went to a dermatologist appointment.She told her dermatologist not to worry, that she was burned from using the thermacare wrap.The dermatologist did not diagnose her with a burn and did not prescribe any therapies.The reporter later verified that she did not seek medical evaluation for her symptoms.The consumer noted that the packaging has changed, and she felt that the new packaging which says 16 hours is misleading.She felt as it read as someone can leave on for 16 hours.She reported that she wore the heat wrap for 16 hours as the box said, and she ended up with 2nd degree burns.She did admit that she did not read the directions and did not read the label prior to using the product.She had been using the products for a long period of time.All the previous labels had a 'wear for 8 hours' written on the front in large print.The new package has 16 hours in large print.She also felt that the labeling that directed her to apply over clothing is ridiculous.She stated she would not be using the product again.As of (b)(6) 2021, her symptoms have almost resolved as the blisters have healed and she only had one small red spot on her right buttock.She denied any pain or open areas.She continued to apply aquaphor to the affected areas and she had been keeping the area covered with a dry clean bandage.No further information regarding the consumer's experience is expected.The consumer also provided information regarding the non-reportable (b)(4).

• 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: 11660795
• Report Number: 3007593958-2021-00003
• Device Sequence Number: 3128567
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/13/2021

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: 07/31/2023
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Device Lot Number: LEF0574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/13/2021
• 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: 79 YR