BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOODNITES UNDERPANTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 8840986 · Received July 30, 2019

    Report

    Report Number
    3003701733-2019-00384
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 29, 2019
    Report Date
    July 30, 2019
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY IS CONDUCTING A REVIEW OF THE DHR (DEVICE HISTORY RECORD) AND SUPPORTING QUALITY RECORDS.

    Description of Event or Problem · 1

    A MOTHER REPORTED THAT HER SON EXPERIENCED A SECOND DEGREE CHEMICAL BURN FROM WEARING THE GOODNITES NIGHT TIME UNDERWEAR. EVERYWHERE THE PRODUCT TOUCHED HIS SKIN TURNED RED AND AFTER OVERNIGHT USE, HIS SKIN BECAME MORE RED AND BLISTERED AND BLED. SHE TOOK HIM TO THE WALK-IN-CLINIC. THE PROVIDER AT THE CLINIC RECOMMENDED SHE USE DESITIN AND DIAGNOSED HIM WITH A CHEMICAL BURN. THEY WENT HOME AND DESITIN WAS APPLIED. THEY ALSO STOPPED USING THE PRODUCT. TWO HOURS AFTER ARRIVING HOME, THE BLISTERS WORSENED AND THE SKIN ON HIS BOTTOM WAS COMPLETELY GONE, HE HAD PAIN AND A FEVER. SHE THEN TOOK HIM TO CHILDREN'S HOSPITAL. FROM CHILDREN'S HOSPITAL HE WAS TRANSPORTED VIA AMBULANCE TO A BURN UNIT WHERE HE WAS DIAGNOSED WITH SECOND DEGREE CHEMICAL BURNS AND WAS ADMITTED FOR THREE DAYS. WHILE ADMITTED TO THE BURN UNIT, HE WAS PUT UNDER IV ANESTHESIA FOR A SURGICAL SCRUB DOWN IN THE OPERATING ROOM. TREATMENTS WERE ALSO DONE WITH SILVADENE SHEETS TO CARE FOR THE BURNS. HE RECEIVED PAIN MEDICATION AND WAS PRESCRIBED A CREAM THAT WAS APPLIED TO THE BURNS. HER SON WAS RELEASED FROM THE HOSPITAL AND WAS HOME AND FEELING BETTER. HE HAD A FOLLOW UP APPOINTMENT WITH THE BURN UNIT AND IT WAS CONFIRMED HE IS DOING BETTER. HE WAS NO LONGER BLISTERED AND BURNS WERE HEALING. THEY WILL FOLLOW UP AGAIN WITH THE BURN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636276 GOODNITES UNDERPANTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY-CLARK CORPORATION NIGHTTIME UNDERWEAR FOR BOYS, S-M PA907215B2142

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R