BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 4212955 · Received October 24, 2014

    Report

    Report Number
    2032896-2014-00346
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    9020023/9040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014. THE EVENTS IMPLANT SITE INFECTION AND DISEASE RECURRENCE ARE ASSESSED AS SERIOUS AND POSSIBLY RELATED TO RESTYLANE. THE EVENTS IMPLANT SITE SWELLING, IMPLANT SITE ERYTHEMA AND IMPLANT SITE PAIN ARE ASSESSED AS NON SERIOUS ADN POSSIBLY RELATED TO RESTYLANE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON 09/05/2014 FROM A (B)(6) FEMALE PT. THE PT'S MEDICAL HISTORY INCLUDED PREVIOUS INJECTIONS WITH OTHER FILLERS. THE PT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) /2014, THE PT WAS BEING INJECTED WITH RESTYLANE IN THE FORM OF HYALURONIC ACID AT A DOSE OF 2 SYRINGES OF 2 ML FOR COSMETIC PURPOSE. IT WAS REPORTED THAT THE PT WAS NOT CERTAIN IF THE PRODUCT WAS RESTYLANE OR RESTYLANE L BUT THOUGHT IT MIGHT BE RESTYLANE BECAUSE THE INJECTIONS WERE PAINFUL AND PROBABLY DID NOT CONTAIN ANESTHETIC. THE BATCH NUMBER USED AND EXPIRY DATE WERE NOT REPORTED. ON (B)(6) 2014, WHILE INJECTING RESTYLANE, THE PT EXPERIENCED SWELLING IN HER RIGHT SIDE EXPERIENCED SWELLING IN HER RIGHT SIDE OF THE FACE AND TENDERNESS AT THE INJECTION SITE. THE PT HAD TAKEN ANTIBIOTICS TO STOP FURTHER SWELLING AND INFECTIONS. IT WAS REPORTED THAT THE PT HAD 4 ROUNDS OF ANTIBIOTICS FOR THE PROCEDURE OF 4 RECURRENT INFECTIONS OF THE RIGHT CHEEKBONE AREA. EACH TIME, IT WAS REPORTED TO THE PHYSICIAN THAT THE AREA HURT AND BECAME RED. THE FIRST TWO OCCASIONS THE PT WAS GIVEN AN ANTIBIOTIC WHICH WAS TAKEN THREE TIMES A DAY FOR TEN DAYS. THE LAST TWO TREATMENTS WERE WITH A ZITHROMAX Z PACK. ON (B)(6) 2014, TREATMENT FOR THE FOURTH TIME WAS PRESCRIBED. WITH EACH TREATMENT, THE INFECTION WOULD GO AWAY AND THEN COME BACK. AFTER THE MOST RECENT TREATMENT, THE CONDITION HAD IMPROVED, BUT MAY BE STARTING UP AGAIN. IT WAS ALSO MENTIONED THAT THE PT HAD A YEAST INFECTION FROM THE ANTIBIOTIC USE. IT WAS ADVISED TO THE PT TO CONTINUE FOLLOWING UP WITH THE PHYSICIAN. THE OUTCOME OF THE EVENTS WAS RESOLVING. THE REPORTER ASSESSED THE EVENTS TO BE POSSIBLY RELATED TO RESTYLANE. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFO IS NOT EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678893 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other