MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/28/2021
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 " she noticed that there were 3 blisters on the application site.She was burned.".The cause of the consumer receiving burns and blisters 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 and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On (b)(6) 20212, a spontaneous report from the united states was received from a consumer regarding an (b)(6) female who was using thermacare lower back and hip 8 hr l/x 2ct.Medical history included back pain and a hospitalization several weeks ago (relative to (b)(6) 2021) which she had sepsis (before using the device).Concomitant products included an unspecified multivitamin.On approximately (b)(6) 2021, the consumer topically applied one thermacare lower back and hip 8 hr l/x (lot number ad3848; expiration date (b)(6) 2021) to her lower back over a tank top for back pain.Approximately 5 hours after she applied the product, she experienced application site burning and had to remove the product.When she removed the product, she noticed that there were 3 blisters on the application site.She was burned.She could see the imprint of the product on her back.The consumer has a nurse which had been looking at the site with each visit.It was clarified that the home nurse that comes to visit her was present to oversee her prior hospital discharge and recovery from her historical sepsis.The nurse was notified of the consumer's reaction.They tried to let it heal but it did not.The nurse advised her to stop use of the product, apply neosporin to the area, and to let the area air dry.On (b)(6) 2021, the home health care nurse told her that the burn and blisters seemed to be healing nicely.The consumer continued to apply neosporin ointment.She had one area that looked like it was a deeper blister, that was not completely healed yet.As of (b)(6) 2021, no additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11916429
• Report Number: 3007593958-2021-00018
• Device Sequence Number: 11778755
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• 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): 06/01/2021

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: 10/30/2021
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: AD3848
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/01/2021
• 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: 83 YR
• Patient Weight: 64