BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOODNIGHTS UNDERPANTS

    MDR report key: 2840678 · Received November 20, 2012

    Report

    Report Number
    1650783-2012-00001
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    KIMBERLY CLARK PARIS PLANT
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. 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

    THE CONSUMER INDICATED THAT HER DAUGHTER DEVELOPED A BUMPY RED IRRITATION ON HER LOWER BACK AND BUTTOCKS AFTER USING GOODNIGHTS. THE CONSUMER STATED THAT HER DAUGHTER SUFFERS FROM JOUBERT SYNDROME WHICH AFFECTS HER MUSCLES, KIDNEYS AND LIVER. SHE INDICATED THAT SHE PUT THE PANTS ON HER DAUGHTER ON SATURDAY, (B)(6) 2012. SHE STATED HER DAUGHTER DEVELOPED A RED BUMPY IRRITATION ON HER LOWER BACK AND BUTTOCKS THE FOLLOWING MORNING. SHE APPLIED CORTISONE 10 OINTMENT FOR THE IRRITATION AND CALAMINE LOTION TO ASSIST WITH THE ITCHING. ON (B)(6) 2012, THE RASH SPREAD TO HER ARMS, LEGS, BUTTOCKS, FEET AND ANUS. THE IRRITATION DEVELOPED INTO PUSS-FILLED POCKETS. SHE VISITED HER DOCTOR THAT SAME DAY. THE CHILD WAS DIAGNOSED WITH A DIAPER RASH THAT DEVELOPED INTO A (B)(6). THE DOCTOR PRESCRIBED BACTROBAN AND CLINDAMYCIN. THE CONSUMER INDICATED THAT THE RASH IS NOT CLEARING AS QUICKLY AS ANTICIPATED BECAUSE HER CHILD IS REJECTING THE MEDICATION. SHE IS GOING TO ATTEMPT TO PUT THE MEDICATION IN THE HER CHILD'S FOOD AND BEVERAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODNIGHTS UNDERPANTS GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY CLARK PARIS PLANT PA222115B2109

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other