BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 629230 · Received August 24, 2005

    Report

    Report Number
    9710154-2005-00022
    Event Type
    Other
    Date Received
    August 24, 2005
    Date of Event
    October 1, 2004
    Report Date
    August 23, 2005
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT A PT UNDERWENT INJECTIONS OF RESTYLANE IN 2004 INTO UPPER LIP FOR AUGUMENTATION. ANESTHESIA IN THE FORM OF A NERVE BLOCK WAS USED PRE-PROCEDURE. AT AN OFFICE VISIT LATER IN 2004, THE PHYSICIAN SAW THE PT AND OBSERVED LUMPS IN THE UPPER LIP. THE PT WAS ADVISED TO GENTLY MASSAGE AREA. IN 2005, THE PHYSICIAN SAW THE PT AGAIN AND OBSERVED LUMPS IN THE UPPER LIP ALTHOUGH SLIGHTLY IMPROVED. THE PHYSICIAN WAS SEEKING INFORMATION. LUMPS 13 MONTH POST-IMPLANT CORRESPOND TO UNEXPECTED FREQUENCY OF A LABELED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NI 7031

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other