BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PESSARY ASSISTANT

    MDR report key: 20453178 · Received October 11, 2024

    Report

    Report Number
    MW5161047
    Event Type
    Injury
    Date Received
    October 11, 2024
    Report Date
    October 8, 2024
    Manufacturer
    UNK
    Product Code
    HHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PESSARY ASSISTANT WAS BROUGHT TO MY ATTENTION AS A DEVICE FOR REMOVING VAGINAL PESSARIES (CODE: HHW, CLASS 2, SUBJECT TO 510(K)). THE DEVICE IS MARKETED AS A TOOL FOR REMOVING PESSARIES, HOWEVER I AM UNABLE TO LOCATE THIS DEVICE IN THE GUDID DATABASE OR ANY OTHER RELEVANT DEVICE OR REGULATORY DATABASES. THE DEVICE DOES NOT APPEAR TO BE LABELLED AS A MEDICAL DEVICE; HOWEVER, IT MAY SATISFY THE DEFINITION OF A MEDICAL DEVICE OR ACCESSORY PER THE CFR. USERS OF THE DEVICE HAVE REPORTED INJURY "THIS PRODUCT IS MADE FROM TOO HARD PLASTIC FOR ITS INTENDED USE - IT NEEDS TO HAVE A SOMEWHAT SOFTER EXTERNAL LAYER. THIS VERY HARD PLASTIC ACTUALLY CUT ME DURING PROPER USE. I WILL NOT USE AGAIN." THE DEVICE IS SOLD BY VARIOUS ENTITIES, INCLUDING AMAZON (HTTPS://A.CO/D/86VDYJE) AND CMT MEDICAL (HTTPS://CMTMEDICAL.COM/PRODUCT/PESSARY-ASSISTANT/).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345374 PESSARY ASSISTANT PESSARY, VAGINAL HHW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability