BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP GLOBAL

    MDR report key: 23858575 · Received December 20, 2025

    Report

    Report Number
    3004824601-2025-00223
    Event Type
    Malfunction
    Date Received
    December 20, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 10, 2026
    Manufacturer
    JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
    Product Code
    MPO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    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 INFHW-ASP REVEALED THE PRIMARY COMPOSITION OF INFHW-ASP TO BE SODIUM ACETATE (CAS 127-09-3). 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 IS TO RINSE THE EXPOSED AREA WITH WATER AND REGARDLESS, EXPOSURE TO INTACT SKIN IS HIGHLY UNLIKELY TO CAUSE LONG-TERM INJURY. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER REPORTED THAT THERE WERE TWO INSTANCES OF INFHW-ASP HEEL WARMER, INFANT EXPLODING ON PATIENT'S HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138164 ASP GLOBAL INFANT HEEL WARMER MPO JIANGSU INTCO MEDICAL PRODUCTS CO., LTD INFHW-ASP K0629EN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown