BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP GLOBAL

    MDR report key: 23852078 · Received December 19, 2025

    Report

    Report Number
    3004824601-2025-00225
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    August 21, 2023
    Report Date
    December 18, 2025
    Manufacturer
    JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
    Product Code
    IMD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. THE MSDS FILE OF IWA03 REVEALED THE PRIMARY COMPOSITION OF IAW03 TO BE SODIUM ACETATE (CAS 6131-90-4). SODIUM ACETATE IS NOT REPORTED AS MEETING GHS HAZARD CRITERIA AND IS NOT CLASSIFIED AS A GHS HAZARD. THE MSDS FILE HAZARD SECTION CONFIRMED THAT IT IS NOT HAZARDOUS AS WELL. SODIUM ACETATE IS EQUIVALENT TO SALT AND VINEGAR SOLUTION. THE MEDICAL RECOMMENDATION FOR NEXT COURSE OF ACTION FOR EXPOSURE TO THE EYES IS TO RINSE THE EXPOSED AREA THOROUGHLY WITH WATER AND REGARDLESS, EXPOSURE IS HIGHLY UNLIKELY TO CAUSE LONG-TERM INJURY. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    ON 21AUG2023, CUSTOMER REPORTED THAT IWA03 PACK, INSTANT WARM, 6"X6.5" EXPLODED ON A PATIENT AND SOME OF THE CONTENTS GOT IN HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256561 ASP GLOBAL WARM PACK IMD JIANGSU INTCO MEDICAL PRODUCTS CO., LTD IWA03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown