BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MM X 2.5MM A

    MDR report key: 787107 · Received November 7, 2006

    Report

    Report Number
    2430952-2006-00042
    Event Type
    Malfunction
    Date Received
    November 7, 2006
    Report Date
    October 6, 2006
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    JYG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTEGRA RECEIVED A USER FACILITY VOLUNTARY 3500A FORM FROM THE FDA ON SEPTEMBER 8, 2006. THE 3500A REFERENCED WHICH IS NOT AN INTEGRA / JARIT PRODUCT ID. UPON RECEIPT OF THE PRODUCT ON SEPTEMBER 20, 2006, THE DEVICE WAS IDENTIFIED AS 385-401. THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE CURRETTE TIP BROKE OFF IN THE EAR OF THE PT. THE TIP WAS RECOVERED. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MM X 2.5MM A JARIT EAR/NOSE JYG HEBUMEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *