BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3170443 · Received June 11, 2013

    Report

    Report Number
    2032896-2013-00176
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    December 5, 2008
    Report Date
    January 27, 2010
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND CONCLUSION OF MFR'S INVESTIGATION: THE EVENTS ARE CONSIDERED TO BE INJECTION SITE ISCHEMIA WHICH RESULTED IN IMPLANT SITE NECROSIS ND IMPLANT SITE SCAR. THE EVENTS ARE PROBABLY RELATED TO THE INJECTION PROCEDURE AND CAUSED BY PRESSURE OCCLUSION OF A BRANCH FROM AN ARTERY. INFO ON BASELINE STATUS HAS NOT BEEN PROVIDED. IT IS UNCLEAR IF PT HAD A PRE-EXISTING SCAR AND IT IS UNCLEAR IF FOREHEAD SCAR IS CORRECTION IS THE AIM FOR RESTYLANE TREATMENT. A TREND ANALYSIS SHOWS THAT THERE ARE NO INCREASED TRENDS OF MEDICAL COMPLAINTS REPORTED FOR LOT NUMBER 9759. PMA # P040024.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED FROM A LAWYER ((B)(6)) AND CONCERNS (B)(6) MALE PT. THE EVENTS ARE CONSIDERED TO BE INJECTION SITE ISCHEMIA WHICH RESULTED IN IMPLANT SITE NECROSIS AND IMPLANT SITE SCAR. THE EVENTS ARE PROBABLY RELATED TO THE INJECTION PROCEDURE AND CAUSED BY PRESSURE OCCLUSION OF A BRANCH FROM AN ARTERY. THE PT WAS TREATED WITH RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) (LOT NUMBER 9759) ON (B)(6) 2008 IN THE GLABELLAR LINES. THE VOLUME INJECTED IS NOT REPORTED. THE ADVERSE EVENTS ARE DARK CLOUD, DARK PATCH OF SKIN ON FOREHEAD, DEAD AREA [IMPLANT SITE NECROSIS] AND ONE OF THE ARTERIES HAD BEEN BLOCKED [INJECTION SITE ISCHAEMIA] WHICH BEGAN ON (B)(6) 2008, 2 DAYS POST RESTYLANE TREATMENT. DISFIGUREMENT / SCARS ON FOREHEAD [IMPLANT SITE SCAR] IS ALSO REPORTED. FORTY-EIGHT HOURS AFTER THE RESTYLANE INJECTION, THE PT NOTICED HE WAS FORMING A "DARK CLOUD" ON HIS FOREHEAD. THE PT WAS TAKEN TO THE ER WHERE HE WAS TOLD THAT ONE OF HIS ARTERIES HAD BEEN BLOCKED. THE PT REQUIRED REPEATED SURGERIES DUE TO THE DISFIGUREMENT OF HIS FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264284 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED 10-70012 9759

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other