BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YOUNG DENTAL STANDARD POINTED PROPHY BRUSH - 090201

    MDR report key: 5641376 · Received May 9, 2016

    Report

    Report Number
    1941138-2016-00013
    Event Type
    Injury
    Date Received
    May 9, 2016
    Report Date
    April 15, 2016
    Manufacturer
    YOUNG DENTAL MANUFACTURING CO 1, LLC
    Product Code
    EHK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTAL OFFICE COMINGLES THEIR BRUSHES, SO WE WERE UNABLE TO DETERMINE THE LOT OR EXPIRATION DATE OF THE BRUSH INVOLVED IN THIS COMPLAINT. THE DENTAL OFFICE DID SEND IN A HANDFUL OF BRUSHES FROM THE DRAWER WHERE THEY COMINGLE (LOT AND EXPIRATION ALSO UNABLE TO BE DETERMINED) FOR EVALUATION. DURING EVALUATION, WE WERE UNABLE TO REPLICATE THE ACTUAL COMPLAINT WHEN RUN ON A HANDPIECE PER MANUFACTURER'S INSTRUCTIONS. SOME BRISTLES WERE ONLY ABLE TO BE REMOVED USING CONSIDERABLE FORCE AND PLIERS. DUE TO A LACK OF INFORMATION IT CAN ONLY BE HYPOTHESIZED THAT THIS EVENT OCCURRED DUE TO THE AGE OF THE BRUSH, POSSIBLY AN EXPIRED LOT WHERE THE GLUE BECAME BRITTLE, OR THAT AN ISOLATED EVENT OCCURRED WHERE THE BRUSH IN THE COMPLAINT DID NOT RECEIVE ENOUGH GLUE. NO OTHER COMPLAINTS OF THIS TYPE HAVE BEEN RECEIVED.

    Description of Event or Problem · 1

    "SENT FROM MY IPHONE PER (B)(6): PATIENT (SHE) (B)(6)- USED BRUSH TO GET STAIN OFF- ONCE IN MOUTH BRISTLES WENT EVERYWHERE - INCLUDING EYE- WHICH PATIENT WENT TO EYE DR. AND DR. SAID OK - DENTIST GAVE PATIENT A CREDIT- BUT SAYS EVERYTHING IS FINE- SHE HAS BEEN IN THIS BUS 33 YRS NEVER SEEN IT BEFORE SENDING A FEW BACK IN THE MAIL DOES NOT HAVE LOT # AND IS IN NO WAY UPSET. I WILL SEND OUT REPLACEMENT DO NOT KNOW SINCE THEY MIX THEM THAT HAD EXPIRED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295561 YOUNG DENTAL STANDARD POINTED PROPHY BRUSH - 090201 STANDARD POINTED PROPHY BRUSH EHK YOUNG DENTAL MANUFACTURING CO 1, LLC 090201 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other