BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACK,HOT,INSTANT,NON-INSULATED,6X10

    MDR report key: 16336828 · Received February 9, 2023

    Report

    Report Number
    1417592-2023-00048
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 9, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2022 WHEN ATTEMPTING TO ACTIVATE THE HOT PACK IT "EXPLODED" COVERING THE PATIENT WITH THE "CONTENTS OF THE PACK" AND GOT INTO THE PATIENT'S "EYE." DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY; THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.S

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2022 WHEN ATTEMPTING TO ACTIVATE THE HOT PACK IT "EXPLODED" COVERING THE PATIENT WITH THE "CONTENTS OF THE PACK" AND GOT INTO THE PATIENT'S "EYE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004763 PACK,HOT,INSTANT,NON-INSULATED,6X10 IMD MEDLINE INDUSTRIES, LP VN22195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other