BEUDAMED
    FDA Adverse Event Other Summary report: N

    POISE

    MDR report key: 5311045 · Received December 16, 2015

    Report

    Report Number
    MW5058588
    Event Type
    Other
    Date Received
    December 16, 2015
    Date of Event
    September 9, 2015
    Report Date
    December 6, 2015
    Manufacturer
    KIMBERLY-CLARK GLOBALSALES, LLC
    Product Code
    EYQ
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INCIDENT: TWO PAINFUL URINARY TRACT INFECTIONS (UTI) AND GROIN SKIN RASH AFTER USING POISE MICROLINERS (FOR LIGHT BLADDER LEAKAGE PROTECTION. INCIDENT DATES: (B)(6) 2015 URINARY TRACT INFECTION DIAGNOSED IN (B)(6). ON (B)(6) 2015 GROIN SKIN RASH DIAGNOSED AT (B)(6) HOSPITAL. ON (B)(6) 2015 URINARY TRACT INFECTION DIAGNOSED AT (B)(6) HOSPITAL. I STARTED USING THESE POISE LINERS IN (B)(6) 2015 BECAUSE I WAS TRAVELING. WOMEN OFTEN WEAR PANTY LINERS TO FEEL "FRESH." I COULDN'T UNDERSTAND WHY I WAS HAVING SO MANY PROBLEMS IN MY GENITAL REGION. I DID SOME RESEARCH AND FOUND AN ABSTRACT ON NIH.GOV WEBSITE THAT DESCRIBES ALLERGIC CONTACT DERMATITIS BECAUSE THE LINERS RESTED POSITIVE FOR (ETH) ACRYLATES. HERE IS THE LINK TO THE ABSTRACT: HHTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/12165934. RETAILER: (B)(6). PURCHASE DATE: 09/01/2015. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831637 POISE POISE MICROLINES (LIGHT BLADDER LEAKAGE PROTECTION) EYQ KIMBERLY-CLARK GLOBALSALES, LLC POISE MICROLINERS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR