BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE-L

    MDR report key: 4265469 · Received November 12, 2014

    Report

    Report Number
    MW5039114
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 3, 2014
    Report Date
    November 12, 2014
    Manufacturer
    GALDERMA
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 05/22/2015. THESE REPORTS WERE ORIGINALLY RECEIVED AND PROCESSED BY (B)(4) NORTH AMERICA LLC, THE PRIOR OWNER OF RESTYLANE-L. IT WAS DETERMINED THAT NONE OF THESE CASES REQUIRED A MEDICAL DEVICE REPORT (MDR).

    Description of Event or Problem · 1

    A (B)(6) MALE INJECTED WITH 1ML OF RESTYLANE USING MICRO-CANNULA FOR TEAR TROUGHS, 0.5 UNDER EACH SIDE. PATIENT EXPERIENCED SEVERE SWELLING, PAIN, ERYTHEMA WITHIN A FEW HOURS OF INJECTION. HIS EYES SWELLED SHUT AND PT. WAS PRESCRIBED 20 MG OF PREDNISONE AND 50 MG OF BENADRYL. COMPLETE RESOLUTION OF SWELLING TOOK ABOUT 2 WEEKS. THIS WAS A NEW LOT OF RESTYLANE HAD RECENTLY RECEIVED AND EVERY PATIENT INJECTED EXPERIENCED SIMILAR REACTIONS. WE SENT BACK THE REMAINING PRODUCT, TO THE COMPANY FOR ANALYSIS BUT COMPANY IS GIVING US THE RUN AROUND SAYING NO ONE ELSE IS HAVING THIS HAPPEN. I KNOW FOR FACT THIS IS NOT TRUE. BEWARE USING RESTYLANE ON YOUR PATIENTS UNTIL THE COMPANY ACKNOWLEDGES THERE IS CURRENTLY A MANUFACTURING ISSUE WITH SOME OF THEIR LOTS. WE HAVE BEEN USING RESTYLANE FOR YEARS AND THIS IS THE FIRST TIME SOMETHING LIKE THIS HAS EVER HAPPENED. SAME REPORTER FOR MW5039112 - MW5039116.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729825 RESTYLANE-L RESTYLANE-L LMH GALDERMA 12399

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention