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

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/28/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3007593958-2022-00057
• Device Sequence Number: 17603463
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male