BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP GLOBAL

    MDR report key: 24553136 · Received March 9, 2026

    Report

    Report Number
    3004824601-2026-00020
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    August 25, 2023
    Report Date
    March 9, 2026
    Manufacturer
    JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
    Product Code
    IMD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NO LOT NUMBER WAS PROVIDED FOR THIS COMPLAINT, THEREFORE THE DHR COULD NOT BE REVIEWED. NO SAMPLES WERE SENT BACK FOR EVALUATION. COMPLAINT FILE HISTORY WAS REVIEWED AND IT WAS CONFIRMED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED ON THIS ITEM FOR LEAKING/RUPTURING. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 0

    ON AUGUST 25, 2025 WE RECEIVED A CUSTOMER COMPLAINT THAT ICA01 PACK COLD, INSTANT, 6X9 HAS A SEAL THAT RUPTURED AND THE CONTENTS SPILLED OUT. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605399 ASP GLOBAL INSTANT COLD PACK IMD JIANGSU INTCO MEDICAL PRODUCTS CO., LTD ICA01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown