BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPG SAFETY NEEDLE

    MDR report key: 1766631 · Received July 13, 2010

    Report

    Report Number
    2925153-2010-00011
    Event Type
    Other
    Date Received
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. THE INFORMATION PROVIDED WITH THE REPORT TO DATE IS SKETCHY. NO PRODUCT LOT NUMBER(S) HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT AS PER THE PERSON MAKING THE REPORT NOTHING MORE IS AVAILABLE. AN EXAMINATION OF THE DEVICE(S) HAS NOT BEEN CARRIED OUT AS THE USED ITEM(S) WAS NOT RETURNED TO NEOMEDICAL.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFORMATION, SUBMITTED TO NEOMEDICAL ON (B)(6) 2010, THE CUSTOMER STATED THAT "WE RECEIVED A CUSTOMER COMPLAINT FOR A DULL NEEDLE." THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE. THE USED PRODUCTS/SAMPLES WERE NOT RETURNED TO NEOMEDICAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPG SAFETY NEEDLE SAFETY NEEDLE FMI NEOMEDICAL SPG-100-21-07 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention