BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE MAXI PADS

    MDR report key: 13757604 · Received March 11, 2022

    Report

    Report Number
    MW5108118
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    February 13, 2022
    Report Date
    March 7, 2022
    Manufacturer
    WAL-MART STORES, INC.
    Product Code
    HHD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING ABOUT AN ADVERSE EVENT AFTER USE OF (B)(6) BRAND MAXI PADS PURCHASED AT (B)(6). SHE STATES SHE NOTICED A HARSH CHEMICAL SMELL UPON OPENING THE BOX. DURING THE COURSE OF PRODUCT USE, SHE DEVELOPED A RASH THAT PROGRESSED TO BLEEDING, ABDOMINAL PAIN, AND BLADDER SPASMS. THESE SYMPTOMS INTERRUPTED HER TYPICAL SLEEP PATTERN AND PERSISTED FOR APPROXIMATELY SEVEN DAYS EVEN AFTER SHE ENDED USE OF THE PRODUCTS. SHE STATES SHE USED TWELVE PADS IN TOTAL. SHE CONTACTED THE TELEPHONE NUMBER LISTED ON THE BOX TO REPORT THIS PROBLEM AND ALSO RETURNED TWO DEVICES TO THEM FOR EVALUATION, PER INSTRUCTION. AFTER EXPRESSING HER CONCERNS TO THEM REGARDING THIS PRODUCT, SHE FELT THEY WERE SOMEWHAT DISMISSIVE AND SO IS REPORTING TO THE FDA TO ENSURE THIS MATTER WILL BE LOOKED INTO. SHE STATES SHE DOES NOT WANT ANYONE ELSE TO EXPERIENCE THE SAME PROBLEMS SHE DID. SHE STATES THE ITEM NUMBER FROM HER PURCHASE RECEIPT IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46766 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    46767 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    46768 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    46769 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    46770 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    46771 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    46772 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    47848 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    47849 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    47850 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    47851 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86
    47852 EQUATE MAXI PADS PAD, MENSTRUAL, UNSCENTED HHD WAL-MART STORES, INC. 22006K86

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other