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

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number was available for evaluation.Without a batch reference number, 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.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a 65-year-old male who used a thermacare lower back and hip 8 hr l/xl heat wrap.Medical history and concomitant products were not provided.On approximately (b)(6) 2022, the consumer applied the thermacare lower back and hip 8 hr l/xl heat wrap to his stomach and then went to bed and fell asleep while wearing the heat wrap.Approximately 8 to 10 hours after sleeping while wearing the heat wrap, he woke up on his side and the skin at the application site was red.The side of his stomach that he slept on was covered with blisters.The consumer's friend advised the consumer not to wear the product directly while sleeping, but he did anyway.It was a burn.The blisters were not open, and they were not getting worse.For treatment, the consumer had been applying an antibiotic ointment to the area.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL
• 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: 15439866
• MDR Text Key: 300068762
• Report Number: 3007593958-2022-00057
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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
• Date Manufacturer Received: 08/31/2022
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male