BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 9158665 · Received October 4, 2019

    Report

    Report Number
    2184163-2019-00008
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 4, 2019
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE SKIN EXPOSURE TO THE SUPER ABSORBENT MATERIAL HAS BEEN DETERMINED BY A MEDICAL PROFESSIONAL TO NOT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    CONSUMER'S WIFE REPORTED THAT HER HUSBAND HAS USED THE DEPEND REAL FIT BRIEFS FOR ABOUT FIVE YEARS AND FOR THE LAST THREE YEARS HE HAS HAD RECURRING URINARY TRACT INFECTIONS. THE LAST OCCURRENCE HE DEVELOPED A BLADDER AND KIDNEY INFECTION AND THEN SEPSIS. HE DID NOT EXPERIENCE INFECTION SYMPTOMS UNTIL THE INFECTION CAUSED HIM TO BECOME SEPTIC AND HE QUICKLY DEVELOPED A FEVER OF 104 DEGREES. HE WAS HOSPITALIZED FOR ONE WEEK AND TREATED WITH IV ANTIBIOTICS AND ORAL ANTIBIOTICS BACTRIM AND CEPHALEXIN WHEN HE WAS SENT HOME. THE INFECTION RESOLVED AND HE WAS DOING WELL. CONSUMER'S WIFE WAS CONCERNED THE DEPEND BRIEFS FALLING APART AND LEAVING THE SUPER ABSORBENT MATERIAL ON HIS SKIN, CLOTHES, AND BEDDING WAS LEADING TO THE INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950023 DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY REAL FIT MAXIMUM L/XL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R