BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE-PAPARELLA CUR, DBL-ENDED

    MDR report key: 921236 · Received March 30, 2007

    Report

    Report Number
    1423507-2007-00030
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Date of Event
    February 26, 2007
    Report Date
    March 29, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED WITH ABOUT 4 TO 5 MM OF ONE END MISSING. VISUAL EXAMINATION OF SURFACE SHOWS NO SIGN OF OXIDATION OR STAINING. FRACTURE STARTED ON INNER SURFACE AND MOVED TO OUTER SURFACE WITH CONTINUED USE. NO ABSOLUTE CAUSE OF THE FAILURE CAN BE DETERMINED, BUT IT IS APPEARS THE PRODUCT FAILED FROM FORCES BEING APPLIED EXCEEDING THE STRENGTH OF THE MATERIAL. HISTORICAL REVIEW SHOWED NO OTHER FAILURES OF THIS TYPE FOR INSTRUMENTS MADE DURING THIS TIME FRAME.

    Description of Event or Problem · 1

    TIP OF CURRETTE BROKE OF DURING A PROCEDURE. BROKEN PIECE HAD TO BE REMOVED FROM THE PATIENT'S EAR. ADDITIONALLY, THE ACCOUNT STATED TIP OF PRODUCT BROKE OFF IN PATIENT'S MIDDLE EAR DURING AN EAR PROCEDURE WHILE THE PHYSICIAN WAS CUTTING BONE. THE BROKEN PIECE HAD TO BE LOCATED AND REMOVED FROM THE PATIENT'S EAR WITH SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE-PAPARELLA CUR, DBL-ENDED CURETTE JYG CARDINAL HEALTH AU13720 A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other