BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEOSYAL RHA 2

    MDR report key: 7395033 · Received April 4, 2018

    Report

    Report Number
    3005975625-2018-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    February 19, 2018
    Report Date
    April 4, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUCH EVENT IS KNOWN AND GENERALLY CAUSED BY A FAILURE TO COMPLY WITH THE NEEDLE-SYRINGE ASSEMBLY DIRECTIONS, WHICH ARE MENTIONED IN THE INSTRUCTIONS FOR USE.THE DESIGN OF THE PRODUCT, WITH A BULT-IN LUER LOCK AND DOUBLE SCREW THREAD NEEDLE-SYRINGE CONNECTION, MAKES NEEDLE DISCONNECTION/EJECTION UNLIKELY TO OCCUR AS LONG AS THE USER SAFELY SCREWED THE NEEDLE ONTO THE SYRINGE.

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). THE INTITIAL REPORTER INDICATED THAT DURING THE USE OF THE PRODUCT, THE NEEDLE WAS EJECTED FROM THE SYRINGE. THE INTITIAL REPORTER INDICATED THAT THERE WERE NOT CLINICAL CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238084 TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP30L-164101B

    Patients

    Seq Age Sex Outcome Treatment
    1