BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 8866050 · Received August 6, 2019

    Report

    Report Number
    2184163-2019-00005
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    June 23, 2019
    Report Date
    August 6, 2019
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.

    Description of Event or Problem · 1

    CONSUMER REPORTED SHE HAS HAD RECURRING URINARY TRACT INFECTIONS WHILE USING THE PRODUCT. SHE WEARS A FIT FLEX BRIEF WITH TWO POISE PADS INSIDE OF IT AND BELIEVED THAT MAY HAVE SOMETHING TO DO WITH HER ISSUES. SHE EXPERIENCED VAGINAL DISCHARGE OF PUS AND BLOOD AND HAS ALSO BEEN GETTING BOILS AND PIMPLES IN THE GENITAL AREA. ONE DAY SHE WENT UNCONSCIOUS AND THE AMBULANCE WAS CALLED. AT THE HOSPITAL THEY DID A DRUG PANEL TEST. THE TEST DID NOT FIND ANYTHING EXCEPT THAT SHE WAS SEVERELY SEPTIC FROM THE UTI. SHE WAS THEN HOSPITALIZED FOR THREE DAYS. AFTER SHE WAS RELEASED SHE DID NOT FEEL WELL FOR A WEEK. SHE RETURNED TO THE DOCTOR AND WAS DIAGNOSED WITH A UTI AGAIN AND GIVEN A NEW MEDICATION. SHE HAD A FOLLOW UP APPOINTMENT WITH A UROLOGY SPECIALIST AND WAS DIAGNOSED WITH ANOTHER UTI. CEPHALEXIN 250MG WAS PRESCRIBED AND SHE WAS FEELING BETTER. SHE HAS STRUGGLED WITH A LOT OF OTHER HEALTH PROBLEMS; HERNIAS, BLADDER BOTOX, ETC. HER DOCTOR RECOMMENDED SHE TRY CANNABIS FOR HER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659710 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY ULTIMATE LONG

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L