BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREGNANCY AND OVULATION DETECTION STRIPS

    MDR report key: 10250231 · Received July 8, 2020

    Report

    Report Number
    MW5095435
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    PREGMATE LLC
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOR CLARITY, I DID NOT PURCHASE THE PRODUCT. HOWEVER, I FELT OBLIGATED TO MAKE A REPORT WHEN I CAME ACROSS CONCERNING INFORMATION. I WAS READING REVIEWS OF THE PRODUCT ON (B)(6) AND NOTICED SEVERAL REVIEWS THAT INDICATE THE COMPANY MAY BE VIOLATING THE LAW. THE COMPANY IS CALLED (B)(6) AND SEVERAL REVIEWERS STATED THEY RECEIVED PREGNANCY AND OVULATION TESTS IN (B)(6) BAGS WITHOUT PROPER LABELS OR PACKAGING. IT APPEARS THEY WERE SENT AS CONSIDERATION FOR THE CUSTOMER MAKING ONLINE REVIEWS. HERE IS A LINK TO ONE SUCH REVIEW: (B)(6). THE FOLLOWING COMMENT WAS MADE (B)(6) 2019: "UPDATE: CHANGED FROM 5 STARS TO 1. TESTED EVERY DAY THROUGH MY OVULATION PERIOD. CLEAR SIGNS OF OVULATION BUT NEVER GOT A POSITIVE READING IN THE STRIP. WILL TRY AGAIN USING IT NEXT MONTH. ALSO FILLED OUT REVIEW THE FIRST TIME TO GE 25 EXTRA STRIPS. THEY SHIPPED TO ME IN A REGULAR ZIP LOCK BAG. WON'T BE USING THOSE SINCE THEY DIDN'T COME IN PROPER PACKAGING." ANOTHER REVIEWER WROTE "THE TESTS CAME IN A PLASTIC BAG" ((B)(6)). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712852 PREGNANCY AND OVULATION DETECTION STRIPS KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER LCX PREGMATE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other