BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARNHART CURETTE

    MDR report key: 4683637 · Received April 10, 2015

    Report

    Report Number
    1416605-2015-00001
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    March 10, 2015
    Report Date
    October 16, 2017
    Manufacturer
    HU-FRIEDY MFG. CO., INC.
    Product Code
    EMS
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRACTICE HAS NOT RETURNED THE BROKEN INSTRUMENT FOR HU-FRIEDY TO EVALUATE. WEIGHT OF THE PT IS NOT KNOWN. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER UDI, ONLY A LOT WHICH IS TIED TO THE DATE OF THE MFR. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE (A) NDA, IND, BLA, AND 510(K) ARE NOT APPLICABLE TO THIS CLASS I DEVICE.

    Description of Event or Problem · 1

    THE TIP OF A HU-FRIEDY BARNHART CURETTE BROKE IN A PT'S MOUTH DURING A PROCEDURE FOR SCALING AND ROOT PLANING FOR THE MAXILLARY RIGHT POSTERIOR SEXTANT AND LOCAL DELIVERY OF A CHEMOTHERAPEUTIC AGENT FOR AILING IMPLANT #3. THE BROKEN TIP WAS NOT VISIBLE ON X-RAYS TAKEN AT THE DOCTOR'S OFFICE. THE DOCTOR ADVISED THE PT TO PROCEED TO THE HOSPITAL FOR EMERGENCY TREATMENT. THE PT WAS ADMITTED TO THE HOSPITAL AND REFERRED TO AN ENT FOR A SCOPING PROCEDURE. IT WAS REPORTED THAT THE TIP WAS VISUALIZED RADIOGRAPHICALLY IN THE LARYNX AND THAT THE INTUBATION PROCESS MAY HAVE PUSHED THE INSTRUMENT TIP DOWN INTO THE ESOPHAGUS. WHILE STILL HOSPITALIZED, THE PT SUFFERED FROM A CARDIAC EVENT. THE PT WAS SENT TO A SECONDARY FACILITY WHERE A CARDIAC CATHETERIZATION, ANGIOPLASTY AND INSERTION OF A CARDIAC STENT WAS ORDERED. THE DENTIST OFFICE IS UNABLE TO CONFIRM IF THE PT RECEIVED ALL OF THE RECOMMENDED PROCEDURES. THE DENTAL OFFICE IS ABLE TO CONFIRM THAT THE PT WAS RELEASED AND AT HOME BY (B)(6) 2015. NO FURTHER MEDICAL PROCEDURES OR THERAPIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240839 BARNHART CURETTE 5/6 BARNHART CURETTE, EVEREDGE EMS HU-FRIEDY MFG. CO., INC. SBH5/69 06/2013

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization ARESTIN| TOPICAL BENZOCAINE 20%| LOCAL ANESTHESIA| ULTRASONIC SCALER PARKELL TURBO ALL