BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVENTH GENERATION

    MDR report key: 12302892 · Received August 10, 2021

    Report

    Report Number
    1648563-2021-00005
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    March 16, 2021
    Report Date
    August 10, 2021
    Manufacturer
    FEMPRO CONSUMER PRODUCTS ULC
    Product Code
    HHD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CONSUMER USED OUR MAXI PADS DURING A HEAVY MENSTRUAL CYCLE. WHILE USING THEY EXPERIENCED A ITCHY AND UNCOMFORTABLE RASH COMPARED TO "DIAPER RASH". THEY DISCONTINUED USE THE FOLLOWING DAY WHEN NOTICING BLISTERS AND SELF MEDICATED WITH COCONUT OIL WHICH STOPPED THE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201843 SEVENTH GENERATION MAXI PAD- ABSORBENCY UNKNOWN HHD FEMPRO CONSUMER PRODUCTS ULC MAXI PAD 11240 FP 03 10:10:19

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR