BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENA INTIMATES INCONTINENCE PADS

    MDR report key: 6763463 · Received August 2, 2017

    Report

    Report Number
    MW5071347
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    June 1, 2017
    Report Date
    August 2, 2017
    Manufacturer
    SCA HYGIENE PRODUCTS
    Product Code
    EYQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT ADVERSE REACTION TO TENA INCONTINENCE PADS. PATIENT STATED SHE HAD BEEN USING THE SERENITY VERSION, WHITE COLORED PAD FOR A LONG TIME. HOWEVER, SHE SAID SHE NOTICED A CHANGE IN THE PRODUCT APPROXIMATELY TWO MONTHS AGO, AND THIS NEW VERSION WAS NOW CALLED SERENITY. PATIENT STATED THAT THE NEW VERSION CONTAINS DYE AND PERFUME WHICH CAUSED HER TO BREAK OUT IN A RASH INSIDE OF HER LEGS. PATIENT SAID SHE DID SPEAK WITH THE MFR TO MAKE THEM AWARE OF THE ISSUE. PATIENT STATED SHE WOULD LIKE TO KNOW IF THE FDA CAN CONDUCT A TEST TO SEE IF DYE IS BAD FOR PEOPLE TO HOPEFULLY HELP REGULATE THE USE OF IT IN PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539647 TENA INTIMATES INCONTINENCE PADS TENA INTIMATES INCONTINENCE PADS EYQ SCA HYGIENE PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other