BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOP CARE BRAND TAMPON

    MDR report key: 8343737 · Received February 14, 2019

    Report

    Report Number
    MW5084123
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    February 4, 2019
    Report Date
    February 12, 2019
    Manufacturer
    TOPCO ASSOCIATES LLC
    Product Code
    HEB
    UDI-DI
    3680025172
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTING TOP CARE BRAND MULTI PACK (REGULAR SIZE) TAMPON, I NOTICED IMMEDIATE DISCOMFORT, TOOK IT OUT AND NOTICED A FOREIGN SUBSTANCE ATTACHED TO THE TAMPON. THE OBJECT ATTACHED IS HARD TO THE TOUCH, BUT THE MATERIAL IS DIFFICULT TO IDENTIFY. IMMEDIATELY CALLED MY DOCTOR TO GET AN APPOINTMENT. AFTER SHOWING HIM THE TAMPON, HE, TOO, COULDN'T IDENTIFY THE EMBEDDED OBJECT, BUT DID A COMPLETE PELVIC EXAM TO MAKE SURE IT DIDN'T SCRAPE THE CERVIX OR LEAVE ANY REMNANTS INTERNALLY. AS OF TODAY, THERE'S NO SIGN OF A BACTERIAL INFECTION OR ILLNESS, BUT THE OVERALL EXPERIENCE HAS BEEN STRESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134902 TOP CARE BRAND TAMPON TAMPON, MENSTRUAL, UNSCENTED HEB TOPCO ASSOCIATES LLC 800221 3680025172

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention