BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRYTIME FOR POTTY TRAINING

    MDR report key: 195952 · Received November 3, 1998

    Report

    Report Number
    3026510-1998-00001
    Event Type
    Other
    Date Received
    November 3, 1998
    Date of Event
    October 17, 1998
    Report Date
    October 22, 1998
    Manufacturer
    HEALTH SENSE INTL
    Product Code
    KPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADVERSE EVENT WAS CALLED IN TO FACILITY ON 10/19/1998. THE PATIENT IS DEVELOPMENTALLY DISABLED AND THE UNIT HAD BEEN PURCHASED TO ESTABLISH A TOILETING SCHEDULE. THIS WAS THE FIRST TIME THEY USED THE UNIT. THE UNIT HAD BEEN POSITIONED ON THE PATIENT AS DIRECTED BY THE PRODUCT INSTRUCTIONS. THE PATIENT HAD BEEN WEARING THE UNIT FOR ABOUT TWO HOURS AND THE CAREGIVER CHECKED THE PATIENT. WHEN THE UNDERGARMENT WAS REMOVED A BURN WAS DISCOVERED. THE BURN WAS LOCATED ON THE STOMACH. THE BURN CONSISTED OF AN AREA WHERE THE SKIN HAD BEEN SCORCHED 1/2" LONG X 1/8" WIDE AND A ROUND AREA ABOUT THE SIZE OF A DIME WITH A SMALL BLACK CENTER. THE CAREGIVER DESCRIBES THE PATIENT AS BEING OVER WEIGHT WITH SEVERAL ROLLS OF SKIN IN THE STOMACH AREA. THE CAREGIVER BELIEVES THAT ONE OF THE METAL CLIPS CAME LOOSE FROM THE SENSE'R STRIP AND BECAME TWISTED. THE UNIT APPEARS TO HAVE BECOME LODGED IN BETWEEN TWO ROLLS OF SKIN MAKING IT DIFFICULT TO NOTICE IT WAS NOT PROPERLY POSITIONED. THE EVENT HAPPENED ON SATURDAY 10/17/98 AND THE CAREGIVER TOOK THE PATIENT TO THEIR DOCTOR ON THE FOLLOWING MONDAY 10/19/98. THE DOCTOR DIAGNOSED THE INJURY AS A CONCENTRATED BURN. THE DOCTOR PRESCRIBED TREATMENT, WHICH IS BEING FOLLOWED BY THE CAREGIVER. THE USE OF THE UNIT WAS IMMEDIATELY DISCONTINUED AND THE UNIT WAS SENT BACK FOR PRODUCT REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRYTIME FOR POTTY TRAINING MOISTURE DETECTION ALARM KPN HEALTH SENSE INTL DRYTIME FOR POTTY TRAINING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other PATIENT TAKING DITROPAN DAILY.