BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED SINUS BURS

    MDR report key: 3873066 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11595
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: BUR, (B)(4), 3PK HI SPEED DIAMOND 70DEG, LOT# H8993378, 510K: EXEMPT, MANUFACTURE DATE: 2013-09-16, EXPIRATION DATE: 2021-09-16. NOTE: THE CUSTOMER USED A TOTAL OF 3 BURS (2 FROM LOT HG02VJH AND 1 FROM LOT # H8993378), TWO BURS BROKE AND; THE THIRD BUR DID NOT BREAK, IT WAS USED TO COMPLETE THE PROCEDURE. IT IS NOT KNOWN WHICH OF THE THREE BURS BROKE. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE USER WAS ABLE TO CLARIFY THAT THREE (3) TOTAL BURS BROKE, AND NONE WILL BE RETURNED. THE FOLLOWING INFORMATION WAS RECIEVED REGARDING THE LOT NUMBERS AND QUANTITIES: "1) REF 1883672HS, LOT H8993378 X1 2) REF 1883672HS, LOT HG02VJH X2".

    Description of Event or Problem · 1

    THE USER WAS ABLE TO CLARIFY THAT THREE (3) TOTAL BURS BROKE, AND NONE WILL BE RETURNED. THE FOLLOWING INFORMATION WAS RECEIVED REGARDING THE LOT NUMBERS AND QUANTITIES: "1) REF 1883672HS, LOT H8993378 X1 2) REF 1883672HS, LOT HG02VJH X2".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO HIGH SPEED BURS BROKE DURING SURGERY. THERE WERE DEVICE FRAGMENTS CREATED, WHICH WERE RETRIEVED WITHOUT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349248 CURVED SINUS BURS BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1883672HS HG02VJH

    Patients

    Seq Age Sex Outcome Treatment
    1