BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A

    MDR report key: 710099 · Received May 3, 2006

    Report

    Report Number
    2430952-2006-00017
    Event Type
    Malfunction
    Date Received
    May 3, 2006
    Report Date
    May 1, 2006
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING A TYMPANOPLASTY PROCEDUR, THE CUP OF HTE CURETTE BROKE OFF. THE SURGEON DOESN'T KNOW IF THE TIP IS IN THE PT'S EAR OR FLEW OFF ONTO THE DRAPE OR FLOOR. THE SURGEON HAS SCHEDULED AN X-RAY TO COFIRM. THE SURGEON REPORTED THAT IF THE INSTRUMENT PIECE IS IN THE PT'S EAR. IT SHOULD NOT CAUSE ANY PROBLEMS, HOWEVER, THE SURGEON HAS QUESTIONED WHETHER IT IS MAGNETIC IN THE EVENT PT REQUIRES AN MRI AT A LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A * FZS HEBUMEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *