BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 8773139 · Received July 9, 2019

    Report

    Report Number
    2184163-2019-00004
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    November 1, 2017
    Report Date
    July 9, 2019
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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'S CAREGIVER REPORTED THAT HER PATIENT HAD BEEN DIAGNOSED WITH REOCCURRING URINARY TRACT INFECTIONS WHILE USING THE DEPEND UNDERWEAR THE PAST THREE YEARS. SHE WAS HOSPITALIZED FOR ONE WEEK IN (B)(6) 2017 FOR A KIDNEY PROBLEM; SHE HAD RASH BUT NO UTI AT THE TIME. SHE RECEIVED ANTIBIOTICS OR FLUIDS. CONSUMER WAS DISCHARGED TO A REHAB FACILITY BUT IS HOME NOW. THE CAREGIVER ALSO REPORTED CONSUMER EXPERIENCED AN ON-GOING RASH, ITCHING, BURNING, BLEEDING TO BUTTOCKS AND BETWEEN LEGS WHICH CAUSED DISCOMFORT AND DISCOLORING TO SKIN; VAGINAL DISCHARGE AND ODOR. SHE RECEIVED MEDICAL ATTENTION FOR RASH AND WAS TREATED WITH CREAM AND (B)(6). RASH WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564563 DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY FIT-FLEX INCONTINENCE UNDERWEAR FOR WOMEN, MAXIMUM ABSORBENCY, MEDIUM

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR