BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOODNIGHTS UNDERPANTS

    MDR report key: 3953317 · Received July 23, 2014

    Report

    Report Number
    1650783-2014-00002
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 24, 2014
    Manufacturer
    PARIS CHILD CARE PLANT
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED BY THE CONSUMER. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS IS NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED THAT HER SON DEVELOPED A CHEMICAL-BURN LIKE RASH ON HIS BACK AND BACKSIDE AFTER UNDERPANT USAGE. HE VISITED HIS PHYSICIAN AND WAS PRESCRIBED A FUNGAL CREAM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432071 GOODNIGHTS UNDERPANTS INCONTINENCE GARMENT EYQ PARIS CHILD CARE PLANT GOODNIGHTS FOR BOYS

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other