BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1671513 · Received April 28, 2010

    Report

    Report Number
    2032896-2010-00014
    Event Type
    Other
    Date Received
    April 28, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 27, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) NUMBER: P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE (AGE REPORTED AS UNKNOWN) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED PREVIOUS INJECTION OF BOTOX (ONABOTULINUMTOXINA) AND RESTYLANE TO THE GLABELLAR AREA; OTHERWISE THE PATIENT HAD NO ALLERGIES OR PAST MEDICAL HISTORY. THE PATIENT'S SKIN TYPE WAS REPORTED AS "2". CONCOMITANT MEDICATIONS INCLUDED ASPIRIN (ACETYLSALICYLIC ACID) 81 MG DAILY. THE PATIENT RECEIVED A 0.4 CC (0.2 CC ON EACH SIDE) INJECTION OF RESTYLANE ON (B)(6) 2010 TO THE GLABELLAR AREA. NO PRE-PROCEDURE MEDICATIONS WERE GIVEN AND NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2010, TEN MINUTES AFTER THE INJECTION, THE PATIENT DEVELOPED A VENOUS THROMBOSIS IN THE GLABELLAR AREA. THE COMPANY REPRESENTATIVE REPORTED THAT THE INJECTING PHYSICIAN "THOUGHT THAT SHE HAD HIT ONE OF THE ARTERIAL AREAS" AND TREATMENT INCLUDED "STANDARD PROTOCOL COMPRESS." ON (B)(6) 2010, THE PATIENT WAS EVALUATED BY THE INJECTING PHYSICIAN AND THE AREA "JUST LOOKED LIKE BRUISING WITH NO INFECTION OR SKIN SLOUGHING." THE PATIENT WAS INSTRUCTED TO MASSAGE THE AREA AND WAS PROVIDED NITROGLYCERIN OINTMENT TO APPLY TO THE AREA. THE INJECTING PHYSICIAN SPOKE WITH THE PATIENT OVER THE NEXT TWO DAYS FOLLOWING THE INJECTION, BUT HAD NOT SEEN THE PATIENT SINCE SHE WAS EVALUATED ON (B)(6) 2010. THE INJECTING PHYSICIAN FELT THAT RESTYLANE CAUSED THE EVENTS. THE INJECTING PHYSICIAN FELT THAT RESTYLANE CAUSED THE EVENTS. THE INJECTING PHYSICIAN ASSESSED THE SEVERITY OF THE EVENTS AS MILD. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNKNOWN. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ASPIRIN (ACETYLSALICYLIC ACID)