MAUDE Adverse Event Report: ZHEJIANG LUMENG HEALTH & TECHNOLOGY CO.,LTD CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD 18 SETTING; HEATING PAD POWERED

Lot Number	CWT02106
Medical Device Problem Codes	Use of Device Problem (1670); Scratched Material (3020)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event reported by the consumer could not be replicated upon evaluation of the returned unit.The cable and the connector show signs of damage that occurred after receipt of the product.It is clearly stated in the product instruction manual that the item should be discarded if it shows any sign of deterioration, wear, or damage.On the pad itself, there is an instruction that states: "check the skin under the pad frequently to avoid burning".Please note, allstar is reporting this event as we are committed to fda compliance.Our investigation concludes that the incident was not the result of a malfunctioning device.
Event or Problem Description
On 29-aug-2025, allstar marketing group received the following report regarding a 37-year-old female consumer in association with the calming heat weighted heating pad and massage pad.On (b)(6) 2025, a few times after using the product, the consumer plugged the product in and applied it across her stomach during her cycle to relieve her cramps.After approximately 10 minutes of product application, she noticed the fabric area was not warm, but the connector was hot.She unplugged the calming heat weighted heating pad and massage pad.Later that day, the skin on her right hip was red, blistered, and painful.She went to an emergency room.She was treated with tylenol (acetaminophen) with codeine for a second-degree burn.She was to apply neosporin to the area and to cover with gauze.At the time of the report, she experienced pain and had not worked for three days.

• Brand Name: CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD 18 SETTING
• Common Device Name: HEATING PAD POWERED
• Manufacturer (Section D): ZHEJIANG LUMENG HEALTH & TECHNOLOGY CO.,LTD; no.356 yue wang road; shaoxing; zhejiang 31200 5,; CH 312005,
• 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: 23099879
• Report Number: 3003799587-2025-00001
• Device Sequence Number: 9503530
• Product Code: IRT
• UDI-Device Identifier: 06973305010026
• UDI-Public: 06973305010026
• 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): 09/19/2025

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 Lot Number: CWT02106
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LEVOTHYROXINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 59 KG