BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP GLOBAL

    MDR report key: 24315184 · Received February 11, 2026

    Report

    Report Number
    3004824601-2026-00017
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 11, 2026
    Manufacturer
    JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED TO ASP ON (B)(6) 2026, CUSTOMER HAD TWO EVENTS OF ASP HEEL WARMERS EXPLODING OUT OF THE PACKAGE UPON ACTIVATION. DATE EVENT OCCURED WAS 17DEC2025, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238851 ASP GLOBAL INFANT HEEL WARMER MPO JIANGSU INTCO MEDICAL PRODUCTS CO., LTD INFHW-ASP J0610EN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown