BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEL-E DONUT

    MDR report key: 3539537 · Received December 20, 2013

    Report

    Report Number
    3539537
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    December 17, 2013
    Report Date
    December 20, 2013
    Manufacturer
    CHILDREN'S MEDICAL VENTURES, LLC
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    GEL-E DONUT SIZE MEDIUM ON SHELF STORAGE NOTED TO HAVE SOME KIND OF BLACK SPOTS THAT LOOK LIKE MOLD INSIDE THEM (INSIDE THE GEL). SENT PRODUCT AND FORM TO MATERIALS MANAGEMENT. ALSO, SENT NOTIFICATION TO NURSING LEADERSHIP, QUALITY/SAFETY LEADERSHIP, MATERIALS MANAGEMENT, AND SUPPLY CHAIN MANAGER. THE DEVICE WAS NOT USED ON A PATIENT. UNKNOWN HOW THE SPOTS CAME TO BE THERE OR EXACTLY WHAT THEY ARE. PRODUCT IS STORED IN A TEMPERATURE & HUMIDITY CONTROLLED ENVIRONMENT; A DRY LOCATION. NO OTHER PRODUCTS IN THIS STORAGE AREA HAD THE SPOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669315 GEL-E DONUT SUPPORT, PATIENT POSITION CCX CHILDREN'S MEDICAL VENTURES, LLC 989805606571 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *