BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIMO FLSP CNT MNT HT

    MDR report key: 11231163 · Received January 26, 2021

    Report

    Report Number
    1825660-2021-00899
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    December 25, 2020
    Report Date
    January 26, 2021
    Manufacturer
    RANIR LLC
    Product Code
    JES
    UDI-DI
    4237914693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER POSTED ON AMAZON: WHEN I TRY TO BEND THE PICK PART BACK FOR USE IT SNAPS OFF. WITH PLACKERS THEY DO NOT SNAP OFF. THE PLASTIC IS JUST A BIT TOO RIGID. FOR THIS REASON I WOULDN'T BUY AGAIN (IN 2 YEARS WHEN I USE ALL OF THESE, LOL) BUT....IF I KNEW THEY FIXED THE ISSUE I DEFINITELY WOULD BUY GAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129566 SOLIMO FLSP CNT MNT HT FLOSS, DENTAL JES RANIR LLC FLSP CNT MNT HT 90 4237914693

    Patients

    Seq Age Sex Outcome Treatment
    1