BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS

    MDR report key: 3080297 · Received April 26, 2013

    Report

    Report Number
    2381757-2013-00015
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 28, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 STATED THAT EXPERIENCED ACUTE RESPIRATORY DISTRESS AS A RESULT OF THE FRAGRANCE WITHIN INCONTINENCE PADS. THE CONSUMER INDICATED THAT SHE STARTED USING THE INCONTINENCE PADS SEVERAL MONTHS AGO AND COULD TASTE THE FRAGRANCE IN HER MOUTH WHILE WEARING THE PADS. SHE ALSO STATED THAT SHE NOTICED AN INCREASE IN COUGHING AND MUCUS PRODUCTION. SHE WAS TAKEN TO THE HOSPITAL ON (B)(6) 2013, AFTER SUFFERING ACUTE SEVERE RESPIRATORY DISTRESS. THE CONSUMER STATED THAT SHE HAS A HISTORY OF MEDICAL ISSUES INCLUDING ASTHMA, HYPERTENSION AND INSULIN-DEPENDENT DIABETES. SHE IS CURRENTLY ON MEDICATION FOR THESE ISSUES. SHE ALSO INDICATED THAT SHE HAS A MOLD ISSUE IN HER HOME AND IS PLANNING TO RELOCATE. SHE PLANS TO FOLLOW-UP WITH HER PULMONOLOGIST TO DETERMINE IF SHE HAS ALLERGIES TO THE INCONTINENCE PAD INGREDIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182521 POISE PADS INCONTINENCE GARMENT EYQ KIMBERLY-CLARK CORPORATION - CONWAY MILL ULTRA ODOR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other