BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATIONAL SUPPLY

    MDR report key: 280912 · Received June 7, 2000

    Report

    Report Number
    280912
    Event Type
    Malfunction
    Date Received
    June 7, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 22, 2000
    Manufacturer
    NATIONAL TATOO
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TATOO MACHINE DID NOT WORK DURING SURGICAL PROCEDURE SO PART OF LEFT NIPPLE RECONSTRUCTION INVOLVING TATOOING WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATIONAL SUPPLY TATOOING MACHINE FZZ NATIONAL TATOO XP-586 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other