BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAX PEARL COMPAK PLASTIC

    MDR report key: 5235215 · Received November 14, 2015

    Report

    Report Number
    MW5057926
    Event Type
    Malfunction
    Date Received
    November 14, 2015
    Date of Event
    November 14, 2015
    Report Date
    November 14, 2015
    Manufacturer
    TAMPAX
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OPENED THE INDIVIDUAL PACKAGING FOR THE TAMPON AND SINCE THE APPLICATOR WAS TRANSPARENT, I SAW A BLACK RING AT THE HED (THE ROUNDED PORTION) WHERE THE APPLICATOR AND TAMPON MEET. I DID NOT USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753881 TAMPAX PEARL COMPAK PLASTIC TAMPAX PEARL COMPAK PLASTIC HEB TAMPAX REGULAR ABSORBENCY

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR RX MEDS: NONE