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

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Burning Sensation (2146); Ulcer (2274)

Event Date 06/26/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via telephone from a 77-year-old male who used a thermacare lower back and hip l/xl 8hr heat wrap.Medical history include pain.Further medical history and concomitant products were not provided.On (b)(6) 2022, the consumer topically applied a thermacare lower back and hip l/xl 8hr heat wrap to his lower back.On (b)(6) 2022, after using the product, the consumer took a shower and felt a burning sensation from a dime size area on his lower back.The area looked like a burn.The heat wrap was intact and without any tears.On (b)(6) 2022, the consumer called a doctor and a nurse advised him to apply aloe vera cream to the affected area.As of (b)(6) 2022, the consumer anticipated making an appointment with her physician.No additional information was provided.

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend was identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 15004792
• MDR Text Key: 295820448
• Report Number: 3007593958-2022-00043
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 73 KG