BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 9877588 · Received March 25, 2020

    Report

    Report Number
    2184163-2020-00001
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    December 31, 2019
    Report Date
    March 30, 2020
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEW/CORRECTED INFORMATION: B2: HOSPITALIZATION - INITIAL OR PROLONGED G7: FOLLOW-UP 1 H2: FOLLOW-UP TYPE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP TO CORRECT B2 TO 'HOSPITALIZATION - INITIAL OR PROLONGED'.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD (DHR), SUPPORTING QUALITY RECORDS, AND TWO COMPANION SAMPLES CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    CONSUMER REPORTED A HALF HOUR INTO WEARING A DEPEND FIT FLEX UNDERWEAR FOR WOMEN SHE BEGAN TO EXPERIENCE A REACTION WITH DISCOMFORT, REDNESS, SWELLING, VAGINAL ODOR AND PAIN. SHE ALLEGED HER ARMS, WRISTS, HANDS AND VAGINA WERE SWOLLEN AND ITCHY. SHE WENT TO THE HOSPITAL VIA AMBULANCE. DURING TRANSPORT SHE WAS GIVEN IV BENADRYL BY EMS. IN THE EMERGENCY ROOM (ER) SHE WAS DIAGNOSED WITH ACUTE CONTACT DERMATITIS AND GIVEN CEFTRIAXONE IV AND ALSO PREDNISONE AND FAMOTIDINE. SHE WAS HOSPITALIZED FOR OBSERVATION FOR TWO NIGHTS AND DISCHARGED HOME WITH TAPERING DAILY ORAL STEROIDS AND DAILY FAMOTIDINE. CONSUMER REPORTED SHE WAS FEELING MUCH BETTER AND HAD RECOVERED FROM HER REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340115 DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY FIT FLEX UNDERWEAR FOR WOMEN, LARGE, MAXIMUM ABSORBENCY LF925918X2222

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O