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	04/29/2021
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" the wrap burned her and there was redness".The cause of the consumer receiving burns and redness 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) 2021, a spontaneous report from the united states was received from a consumer regarding a female consumer who used thermacare lower back and hip l/xl 8hr 2ct.Medical history included back pain.Concomitant products were not provided.On the night of (b)(6) 2021, the consumer topically applied the thermacare lower back and hip l/xl 8hr 2ct.On an unspecified amount of time after applying the product, the consumer removed the wrap.She noted her skin was burned and she had blisters.The consumer mentioned she contacted her lawyer.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: 11872780
• Report Number: 3007593958-2021-00017
• Device Sequence Number: 3911786
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/24/2021

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: 08/01/2023
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: EC7090
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/24/2021
• 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