BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOP CARE EVERYDAY USE TAMPONS

    MDR report key: 13093442 · Received December 27, 2021

    Report

    Report Number
    MW5106288
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 23, 2021
    Report Date
    December 23, 2021
    Manufacturer
    TOPCO ASSOCIATES LLC
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TOP CARE 'EVERYDAY' REGULAR ABSORBENCY TAMPON UNRAVELLED AND FELL APART INSIDE VAGINA DURING ATTEMPTED REMOVAL AT 4 HOURS OF WEAR. FAMILY FARE, TOP CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986122 TOP CARE EVERYDAY USE TAMPONS TAMPON, MENSTRUAL, UNSCENTED HEB TOPCO ASSOCIATES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female IRON