BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE INSTRUMENT CO CURETTE

    MDR report key: 11207403 · Received January 20, 2021

    Report

    Report Number
    MW5098907
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    April 1, 2020
    Report Date
    January 15, 2021
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USING IN PROPER FASHION, BROKEN HANDLE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101824 LIFE INSTRUMENT CO CURETTE CURETTE, SURGICAL, GENERAL USE FZS LIFE INSTRUMENT CORP. 712-1001-2 06-12M

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR