BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-PRO PLUS

    MDR report key: 2012351 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01295
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FINDING SAFE-T-PRO PLUS DEVICES DISASSEMBLED IN THEIR BOXES. THIS COULD COMPROMISE THE STERILITY OF THESE SINGLE-USE LANCET DEVICES. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-PRO PLUS DISPOSABLE HOSPITAL LANCET FMK ROCHE DIAGNOSTICS NA R218022

    Patients

    Seq Age Sex Outcome Treatment
    1