BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVENTH GENERATION

    MDR report key: 12302228 · Received August 10, 2021

    Report

    Report Number
    1648563-2021-00004
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    January 5, 2021
    Report Date
    August 10, 2021
    Manufacturer
    FEMPRO CONSUMER PRODUCTS ULC
    Product Code
    HHD
    UDI-DI
    00732913450008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CONSUMER USED OUR REGULAR MAXI TAMPON. AFTER USE SHE NOTICED SKIN IRRITATION ONLY IN AREAS WHERE ADHESIVE CAME IN DIRECT CONTACT WITH SKIN AFTER MOVEMENT OF THE PAD. CONSUMER DISCONTINUED USING PRODUCT AND NO MEDICAL TREATMENT WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197269 SEVENTH GENERATION MAXI PAD- REGULAR HHD FEMPRO CONSUMER PRODUCTS ULC 67245369 20 167 FP7 07:01:32 00732913450008

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR