BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNISTIK 2 EXTRA

    MDR report key: 4356249 · Received November 20, 2014

    Report

    Report Number
    1058602-2014-00004
    Event Type
    Other
    Date Received
    November 20, 2014
    Date of Event
    October 14, 2014
    Report Date
    November 20, 2014
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMK
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REPORTED TO OWEN MUMFORD ON (B)(6) 2014: (B)(6) REPORTED THAT A DONOR SUFFERED AN INFECTION IN HER FINGER AFTER IT WAS PRICKED WITH A UNISTIK 2 LANCET. FIRST LANCET USED DID NOT APPEAR TO PUNCTURE SKIN. SECOND LANCET USED AND SAMPLE WAS TAKEN FROM A DIFFERENT FINGER THAN 1ST ATTEMPT. ON (B)(6) 2014, DONOR'S FATHER CALLED TO SAY HIS DAUGHTER'S FINGER WAS RED & SWOLLEN AND THAT THE SCHOOL NURSE REFERRED HER TO IMMEDIATE CARE, WHERE A PIECE OF LANCET WAS REPORTED TO HAVE BEEN REMOVED. AN ANTIBIOTIC WAS GIVEN TO THE DONOR. MFR REF#: 8021764-2014-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754933 UNISTIK 2 EXTRA SAFETY LANCET FMK OWEN MUMFORD LTD AT 0714 J4282

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other