BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY 5-68 BARNHART CURETTE, RESINEIGHT

    MDR report key: 2278797 · Received September 30, 2011

    Report

    Report Number
    1416605-2011-00002
    Event Type
    Other
    Date Received
    September 30, 2011
    Date of Event
    September 1, 2011
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EKE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT OF PT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE THE INFO. HU-FRIEDY 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. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE A EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE.

    Description of Event or Problem · 1

    CURETTE WITH A RESIN HANDLE BROKE OFF AT SHANK PRIOR TO SCALING PROCEDURES, WHILE DOING SOME EXPLORING WITHIN THE MOUTH. AN AMBULANCE WAS CALLED AND THE PT WAS TRANSPORTED TO THE LOCAL HOSPITAL AND WENT TO THE EMERGENCY ROOM. THE BROKEN TIP WAS REMOVED FROM THE GI TRACT BY A ENDOSCOPIC PROCEDURE. PT IS DOING FINE, NO ADDITIONAL MEDICAL PROCEDURES OR TREATMENT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY 5-68 BARNHART CURETTE, RESINEIGHT SBH5-68 EKE HU-FRIEDY MFG. CO., LLC SBH5/68 U11

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other