BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO NEEDLES

    MDR report key: 1696487 · Received May 18, 2010

    Report

    Report Number
    MW5016033
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TERUMO NEEDLES -LOT 0903006, EXPIRE 03/14- PACKAGED IN PLASTIC BAGS FROM (B) (4), WITH LABELS LISTING EXP DATE AS "01-31-99". OTHER PACKAGED NEEDLES WERE PACKAGED WITH A LABEL LISTING THE EXP DATE AS 01-31-14. PRODUCT IS SENT TO INJECT THE PRODUCT RESTYLANE. (B) (4). DATES OF USE: (B) (6) 2010 -- (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: TO INJECT THE PRODUCT RESTYLANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO NEEDLES NEEDLES FMI MEDICIS AESTHETICS, INC. 0903006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other