MAUDE Adverse Event Report: GUANGDONG OKAY TECHNOLOGY CO.,LTD. CALMING HEAT BACK WRAP BASIC; PAD, HEATING, POWERED

Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report was received on (b)(6) 2023 which regarded a female consumer (age not provided) in association with the calming heat back wrap.On (b)(6) 2023, the consumer used a calming heat back wrap.While using the product she felt a burning sensation on her back.She removed the heat wrap and discovered she had a quarter sized blister on the right side of her back.She was transported to the hospital.She was noted to have second degree burns.She was admitted and discharged from the hospital on the same day on (b)(6) 2023.No further information was provided.
Additional Manufacturer Narrative
There is an instruction that states: "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.

• Brand Name: CALMING HEAT BACK WRAP BASIC
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): GUANGDONG OKAY TECHNOLOGY CO.,LTD.; no.1374, jinjing road; pingnan village; sanxiang town, ; CH
• Manufacturer (Section G): ALLSTAR MARKETING GROUP; 2 skyline drive; hawthorne NY 10532
• Manufacturer Contact: chen liu ; 2 skyline drive; hawthorne, NY 10532 ; 9143477827
• MDR Report Key: 24627097
• Report Number: 3003799587-2026-00006
• Device Sequence Number: 13008283
• Product Code: IRT
• UDI-Device Identifier: 06936189900715
• UDI-Public: 06936189900715
• 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): 03/18/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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