BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISTIK 3

    MDR report key: 8372307 · Received February 26, 2019

    Report

    Report Number
    8021764-2019-00001
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    September 7, 2018
    Report Date
    February 26, 2019
    Manufacturer
    OWEN MUMFORD LIMITED
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LOT NUMBER WAS NOT DISTRIBUTED IN THE US, HOWEVER, THE SAME MODEL NUMBER AT1042 UNISTIK 3 COMFORT WAS DISTRIBUTED IN THE US. ORIGINALLY SENT REPORT ON 29 JAN 2019, HOWEVER, DID NOT REALIZE THE REPORT ERRORED UNTIL TODAY, 26 FEB 21019. RESENDING AS 2019-00001 (8021764, 1058602).

    Description of Event or Problem · 1

    OWEN MUMFORD LIMITED RECEIVED A COMPLAINT FROM (B)(6) - DID NOT RETRACT IN TWO INCIDENTS. THE LOT NUMBERS REPORTED ON THE FILE WERE 029138 & 029556, HOWEVER THE LOT NUMBER RETURNED WAS 029945. IT WAS REPORTED THAT THE NURSE WAS INJURED WHEN THE NEEDLE DID NOT RETRACT INTO THE BODY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162729 UNISTIK 3 SAFETY LANCETS FMK OWEN MUMFORD LIMITED AT 1042 029945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other