BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP GLOBAL

    MDR report key: 24553137 · Received March 9, 2026

    Report

    Report Number
    3004824601-2026-00021
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 21, 2024
    Report Date
    March 9, 2026
    Manufacturer
    JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 (B)(6) 2024 WE RECEIVED A CUSTOMER COMPLAINT THAT RGPA610 PACK, REUSABLE HOT/COLD 6X10 W/SLEEVE WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605400 ASP GLOBAL INSTANT COLD PACK IMD JIANGSU INTCO MEDICAL PRODUCTS CO., LTD RGPA610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown