BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENSTRUAL PADS

    MDR report key: 17560203 · Received August 15, 2023

    Report

    Report Number
    MW5144620
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 13, 2023
    Manufacturer
    UNKNOWN
    Product Code
    HHD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ATTENTION DUE TO ITS CONTENT THIS MESSAGE IS TO BE SEEN BY WOMEN ONLY. I PURCHASED ON (B)(6) 2023 AT (B)(6) TWO PACKS WITH 48 PADS OF REGULAR SIZE MAXI WINGLESS. THESE COME PACKED IN A BLUE PLASTIC BAG WITH A PHOTO OF THE PAD ON IT AND THESE ARE WALGREENS BRAND. IT SAYS ON THE TOP LEFT CORNER OF THE PACKAGE THAT IS WRITTEN:" COMPARE TO ALWAYS REGULAR SIZE 1"***. DISTRIBUTED BY (B)(4) AND THE ITEM # IS 901 360 AND THERE IS (B)(4). UPC BAR CODE# 049022 83746 1 ****23 037 K82 17:18 ***. I BELIEVE THIS NUMBER BETWEEN THE ASTERIXES IS THE LOT NUMBER. I USED THESE IN (B)(6) AND THEY HAD A BAD PLASTICY CHEMICAL ODOR AND THEY CAUSED ME TO HAVE SKIN IRRITATION, ITCHINESS AND INFECTION DOWN THERE AT THE GENITAL AREA. I EVEN HAVE URINE TEST THAT SHOWS INFECTION WHILE I USED THESE IN (B)(6) 2023. PLEASE GET THESE PADS INSPECTED AND DO WHAT IS NEEDED TO BE DONE. THESE HAVE TO BE REMOVED OUT OF THE MARKET. PLEASE AND THANKS AND SEND US FOLLOW UP REPORTS IN REGARDS TO OUR COMPLAINTS. THANKS! REPORT DATE AUGUST 13TH OF 2023. WALGREENS. REFERENCE REPORT: #MW5144621.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199090 MENSTRUAL PADS PAD, MENSTRUAL, UNSCENTED HHD UNKNOWN 23 037 K82 17:1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other