BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN SYRINGE

    MDR report key: 245999 · Received October 25, 1999

    Report

    Report Number
    MW1017397
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    October 14, 1999
    Report Date
    October 25, 1999
    Manufacturer
    RUGBY LABORATORIES, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM THE DIST. ON 11/17/1999. PLEASE NOTE THAT RUGBY IS THE DISTRIBUTOR ONLY, NOT THE MFR OF THE PRODUCT. HOWEVER, RUGBY HAS INITIATED A COMPLAINT AND FORWARDED THE INFO TO THE SUPPLIER WHO WILL SUBSEQUENTLY FORWARD IT TO THE MFR (LOCATED IN KOREA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN SYRINGE 28G 1/2" NEEDLE 1/2CC 50U SYRINGE FMF RUGBY LABORATORIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other