MAUDE Adverse Event Report: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. HENRY SCHEIN, INC.; INSTANT SUMMER HOT 6X8.25

Catalog Number	499-0813
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 40-year-old female patient was undergoing capillary blood collection when a hot pack was applied to warm the skin.For the first 30 seconds, the hot pack was placed directly on the skin, after which a cloth was used as a barrier for the remaining duration, totaling approximately two minutes of application.As a result, the patient sustained a second-degree burn on the left upper arm and a first-degree burn on the right upper arm, requiring first aid treatment.There was no leakage from the product onto the patient.The burns have since healed.

• Brand Name: HENRY SCHEIN, INC.
• Common Device Name: INSTANT SUMMER HOT 6X8.25
• Manufacturer (Section D): JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.; 298 yandunshan rd. dagang; zhenjiang, jiangsu 21213 2; CH 212132
• MDR Report Key: 23849496
• Report Number: 2411236-2025-00003
• Device Sequence Number: 15942350
• Product Code: IMD
• UDI-Device Identifier: 00304040037119
• UDI-Public: (01)00304040037119
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/19/2025
• Report Date (Section F): 12/19/2025

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: Health Professional
• Device Expiration Date: 04/26/2026
• Device Catalogue Number: 499-0813
• Device Lot Number: 250426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2025
• Event Location: Other
• Date Report to Manufacturer: 12/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• 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 Age: 40 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/19/2025