BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PERI-PAD

    MDR report key: 3809646 · Received April 25, 2014

    Report

    Report Number
    3008403546-2014-00001
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 31, 2014
    Manufacturer
    DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ACTIVATION OF THE COLD PACK, THE PAD AND OUTER BAG RUPTURED. FLUID FROM THE PAD CAME INTO CONTACT WITH A NURSE'S EYE CAUSING IRRITATION. AFTER RINSING HER EYE FOR 10 MINUTES, THE NURSE WAS SENT TO THE EMERGENCY ROOM WHERE HER EYE WAS WASHED FOR AN ADDITIONAL 5 TO 10 MINUTES. A PH TEST INDICATED NORMAL LIMITS AND A DYE TEST DETECTED A BURN LOCATED IN THE LOWER PART OF HER RIGHT EYE, WITH NO PITTING OBSERVED. THE NURSE WAS PROVIDED SALINE IF HER EYE BECAME DRY AND RETURNED TO WORK. DURING A FOLLOW-UP EXAMINATION ON (B)(6), THE BURN WAS NO LONGER DETECTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252124 COOL PERI-PAD PACK, HOT OR COLD, DISPOSABLE IMD DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD. CP24

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention