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	Excessive Heating (4030)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/19/2021
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 for 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 the product "painful open sores to the application site".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On (b)(6) 2021, a spontaneous report was received from a consumer regarding a (b)(6) female consumer who used the thermacare neck/shoulder/wrist heat wrap.Medical history included neck and shoulder tension, prior use of thermacare products, and an inactive thyroid.Concomitant products included synthroid (levothyroxine) taken daily.On (b)(6) 2021, the consumer applied the thermacare neck/shoulder/wrist heat wrap (lot number and expiration date not provided) to her neck and shoulder area to help relieve tension in her neck and shoulders.She wore the product for approximately 7 hours while she was at work.When she arrived home, she removed the product.On (b)(6) 2021, after the consumer woke up, she took a shower and while in the shower she noted painful open areas to the application site.She reported there were open sores.It was painful and very sensitive.For treatment she applied aloe and burn relief cream to the affected areas.She did not seek a medical doctor for her symptoms.The consumer did not have the package of the product.As of (b)(6) 2021, the open sores were healing, and they appeared to be scabbing over.They were not painful unless they were touched.Multiple follow up attempts were initiated but were unsuccessful.

• 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: 11858043
• Report Number: 3007593958-2021-00012
• Device Sequence Number: 3790048
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/20/2021

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 Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/20/2021
• 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: 47 YR
• Patient Weight: 59