BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT PACK, MEDIUM, 6X6.5IN

    MDR report key: 8695576 · Received June 13, 2019

    Report

    Report Number
    1423537-2019-00324
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    January 28, 2019
    Report Date
    June 13, 2019
    Manufacturer
    MO016 MO-MOBERLY
    Product Code
    IMD
    UDI-DI
    10630140013751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS COMPLETED ON THE REPORTED LOT V8S254. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THE ISSUE HOT PACK WAS DISCARDED AT THE CUSTOMER¿S LOCATION. WE DID RECEIVE 26 SAMPLES FROM THE SAME LOT ON 6/6/2019. NONE OF THE SAMPLES WERE ACTIVATED, ALL WERE INTACT. THE SITE QUALITY ENGINEER ACTIVATED THE SAMPLES WITHOUT ANY ISSUE. THEREFORE, THE ROOT CAUSE FOR THE BURST HOT PACK COULD NOT BE DETERMINED. AT THIS TIME NO CORRECTIVE ACTION WILL BE TAKEN. WE WILL CONTINUE MONITORING OUR CUSTOMER COMPLAINTS DATA BASE FOR THIS AND ANY OTHER ISSUE REPORTED OF THE SAME NATURE.

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE HOT PACK ALLEGEDLY SPRAYED INTO A REGISTERED NURSE'S EYE REPORTEDLY CAUSING A SCRATCHED CORNEA AS THE CRYSTALS BEGAN TO FORM. THE REGISTERED NURSE WAS SEEN IN EMPLOYEE HEALTH. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER DUE TO PROTECTED HEALTH INFORMATION (PHI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489353 HOT PACK, MEDIUM, 6X6.5IN PACK, HOT OR COLD, DISPOSABLE IMD MO016 MO-MOBERLY 11450-040 V8S254 10630140013751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other