BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1403315 · Received June 10, 2009

    Report

    Report Number
    2032896-2009-00013
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    May 23, 2009
    Report Date
    June 8, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)# P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED A PREVIOUS INJECTION OF RESTYLANE ON (B)(6) 2008 WITH NO PROBLEMS. CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE ON(B)(6) 2009 TO THE VERMILLION BORDER USING THE SYRINGE SAVED FROM THE PATIENT'S PREVIOUS INJECTION ON (B)(6) 2008 (VOLUME INJECTED WAS NOT REPORTED) . IT IS UNKNOWN IF THE PATIENT RECEIVED ANY PRE-PROCEDURE MEDICATIONS. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. WITHIN 2 DAYS OF THE INJECTION, ON APPROXIMATELY (B)(6) 2009, THE PATIENT DEVELOPED TINY WHITE BUMPS IN THE INNER AND OUTER PARTS OF HER MOUTH. THE PATIENT ALSO NOTED THAT A SALIVARY GLAND BETWEEN THE INNER AND OUTER SIDE OF HER MOUTH WAS BLOCKED; IT WAS FILLED WITH FLUID AND SWOLLEN. THE PATIENT WAS SEEN BY A DENTIST WHO DIAGNOSED THE WHITE BUMPS AS FORDYCE SPOTS. AS OF 06/04/2009, THE PATIENT HAD NOT BEEN SEEN IN THE INJECTING PHYSICIAN'S OFFICE AND HAD NOT RECEIVED TREATMENT. THE NURSE STATED THAT SHE WAS NOT SURE IF THIS WAS AT ALL RELATED TO THE PRODUCT. THE LOT NUMBER AND EXPIRATION DATE WERE 9346 AND 08/2010, RESPECTIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9346

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR