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	Excessive Heating (4030)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause cannot 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 " became too hot".The cause of the consumer stating the wrap "became too hot" is inconclusive since review of records does not provide evidence to support defective product.
Event or Problem Description
On (b)(6) 2021, a spontaneous report from the united states was received from a consumer via telephone regarding a female (reporter declined to provide the consumer's age; she was a senior) who was using thermacare lower back and hip 8hr l/xl.Medical history included prior use of thermacare for years and "several pain conditions." the reporter refused to provide additional medical history or information regarding concomitant products.Three weeks prior to (b)(6) 2021, the consumer topically applied one thermacare lower back and hip 8hr l/xl heat wrap (lot number: ek9242, expiration date: 31-oct-2023) to her lower back directly on the skin.Within a few minutes, it became too hot.Subsequently, she doubled over a hand towel and put it between the wrap and her skin.After it was on for 15 minutes, it again became so hot that she was very uncomfortable, and she wanted to remove it.She asked a stranger to remove it for her in a restroom and she put it her purse.Her discomfort resolved soon as the heat wrap was off.There was no further discomfort nor injury.She was asymptomatic.The heat wrap became very hot inside her purse.The consumer noted that the heat wrap must be defective because of this.The consumer did not want to provide any further information regarding her health.

• 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
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 1100 market street suite 600; chattanooga TN 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 12811634
• Report Number: 3007593958-2021-00043
• Device Sequence Number: 4542997
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: EK9242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female