BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY 13/14L COLUMBIA UNIVERSITY CURETTE

    MDR report key: 1981244 · Received February 1, 2011

    Report

    Report Number
    1416605-2011-00001
    Event Type
    Other
    Date Received
    February 1, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 1, 2011
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EIX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT OF PT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE THE INFO. (B)(4) DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT # WHICH IS TIED TO THE DATE OF MANUFACTURE. SINCE THE INSTRUMENT WAS NOT RETURNED WE WERE NOT ABLE TO DETERMINE THE LOT NUMBER. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE.

    Description of Event or Problem · 1

    PT WENT FOR A ROUTINE CLEANING AND DURING THE PROCEDURE THE TIP OF THE INSTRUMENT ((B)(4)) BROKE IN THE PT'S MOUTH AND THE PT SWALLOWED THE TIP. PT WENT TO THE HOSPITAL AFTER THE INCIDENT, THE HOSPITAL PERFORMED AN X-RAY TO CONFIRM THE TIP HAD BEEN SWALLOWED AND SUBSEQUENTLY DID AN ENDOSCOPIC PROCEDURE TO REMOVE THE BROKEN PIECE. DUE TO THE AGE OF THE PT, THE HOSPITAL DID NOT WANT TO WAIT TO SEE IF THE TIP WOULD PASS NATURALLY AND FELT THE NEED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY 13/14L COLUMBIA UNIVERSITY CURETTE SC13/149 EIX HU-FRIEDY MFG. CO., LLC SC13/149 Z9

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other