BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND BUR, HIGH SPEED

    MDR report key: 4140912 · Received October 3, 2014

    Report

    Report Number
    1045254-2014-00241
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. QUANTITY 2 OF MODEL # 1883262HS, LOT # 0208369195 BUR 1883262HS 3PK RND HI SPEED 3.2MM, LOT # 0208328219, QUANTITY 2, MANUFACTURE DATE: 2014-05-07, 510K: EXEMPT (B)(4). EMPTY POUCHES WERE RETURNED ON (B)(4) 2014 WITH NO DEVICES. THUS THE PRODUCT ANALYSIS COULD NOT BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 4 BURS BROKE DURING SURGERY. THE BURS BROKE AT THE CONNECTION POINT TO THE HAND PIECE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619079 ROUND BUR, HIGH SPEED BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883262HS 0208369195

    Patients

    Seq Age Sex Outcome Treatment
    1