MAUDE Adverse Event Report: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. HENRY SCHEIN; COLD COMPRESS INSTANT DISPOSABLE

Lot Number	025HSN31002
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient reports that he applied the disposable instant cold compress wrapped in a towel over his tee shirt for a backache.The disposable instant cold compress was applied to the area for 20 minutes.The patient sustained second degree burns and bursting blisters.The patient claims that the burns were the size of the disposable instant cold compress.The patient is undergoing treatment as a result.
Event or Problem Description
This report provides additional information for the incident initially reported on (b)(6) 2025.The reporter stated that the instant cold compress had been stored in the freezer and was removed prior to use.

• Brand Name: HENRY SCHEIN
• Common Device Name: COLD COMPRESS INSTANT DISPOSABLE
• Manufacturer (Section D): JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.; 298 yandunshan rd., dagang; zhehnjiang, jiangsu 21213 2; CH 212132
• MDR Report Key: 23838918
• Report Number: 2411236-2025-00004
• Device Sequence Number: 9817171
• Product Code: IMD
• UDI-Device Identifier: 00304040037072
• UDI-Public: (01)00304040037072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: Lay User/Patient
• Device Lot Number: 025HSN31002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2025
• Event Location: Home
• Date Report to Manufacturer: 12/18/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement 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 Sex: Male
• Date Report Sent to FDA: 12/19/2025