BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA THIN LONG SUPER WITH WINGS PANTILINER

    MDR report key: 1222209 · Received November 5, 2008

    Report

    Report Number
    MW5008894
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 22, 2008
    Report Date
    November 5, 2008
    Manufacturer
    WALGREENS
    Product Code
    HHD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED WALGREEN'S PANTILINER. I DEVELOPED A BURN AND GASH IN VAGINAL AREA. I FELT PAIN AND IMMEDIATELY REMOVED PANTILINER. THERE WAS NO MENTION OF MATERIALS USED IN THE ITEM. I COULD NOT SIT OR STAND CAUSE OF PAIN!, I MADE AN APPT WITH MY GYNECOLOGIST 2000 AND SHE CONFIRMED I HAD A SEVERE REACTION TO PANTILINER. SHE MENTIONED MATERIAL SAFETY DATA SHEET AND RECOMMEND I CALL WALGREENS AND ASK ABOUT THIS. I CALLED TWO DAYS LATER AND SPOKE AND TOLD HER MY PROBLEM, SHE MENTIONED THEY ARE NOT OBLIGATED TO LIST MATERIALS USED IN THEIR PRODUCTS. ON THE FOLLOWING MONTH, I RECEIVED A MEMO FROM FIRST QUALITY PRODUCTS, INC. STATING "FIRST QUALITY PRODUCTS MANUFACTURERS FINISHED GOODS IN COMPLIANCE WITH THE REQUIREMENTS OUTLINED IN FDA QSR/GMP FOR CLASS 1 EXEMPT DEVICE. THIS MEMO WAS NOT EVENT SIGNED- FURTHER IN MEMO "PRODUCTS MANUFACTURED BY FQP DO NOT REQUIRE MATERIAL SAFETY DATA SHEET TO BE SUPPLIED TO PURCHASERS OF THE PRODUCTS. COMPONENTS OF FIRST QUALITY PRODUCTS INCONTINENCE MGMT PRODUCTS MAY INCLUDE: POLYETHYLENE OR POLYPROPYLENE FILMS AND FABRICS- THIS IS WHAT I BELIEVE CAUSED MY PROBLEM- I DEFINITELY THINK THERE SHOULD BE A REQUIREMENT TO LIST ALL INGREDIENTS FOR PEOPLE LIKE ME WHO DO HAVE REACTIONS TO MATERIAL BEFORE A PRODUCT IS USED NOT AFTER." DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA THIN LONG SUPER WITH WINGS PANTILINER PANTILINER HHD WALGREENS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Disability