BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1376068 · Received May 6, 2009

    Report

    Report Number
    2032896-2009-00006
    Event Type
    Other
    Date Received
    May 6, 2009
    Date of Event
    April 21, 2009
    Report Date
    May 6, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P020023. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE OTHER SUSPECT MEDICAL DEVICE IDENTIFIED IN THIS REPORT, PERLANE, HAS BEEN REPORTED AS MRN# 2032896-2009-00007 (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN ASSISTANT (PA) REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OS RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) AND AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED AN ALLERGY TO PENICILLIN. CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED INJECTIONS OF RESTYLANE, 4 CC TOTAL (4 SYRINGES), AND PERLANE, 2 CC TOTAL (2 SYRINGES), ON (B)(6) 2009 TO THE NASOLABIAL FOLDS. PRE-PROCEDURE MEDICATIONS INCLUDED TOPICAL BETACAINE WITH 99% ALCOHOL AFTERWARD. IT IS UNKNOWN IF ANY ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. INITIALLY, THE PATIENT WAS VERY PLEASED WITH THE RESULT. ON (B)(6) 2009, THE PATIENT REPORTED REDNESS AND THOUGH SHE MIGHT HAVE AN INFECTION. ON (B)(6) 2009, THE PATIENT WAS PRESCRIBED KEFLEX (CEPHALEXIN; DOSAGE UNKNOWN). ON (B)(6) 2009, THE PATIENT REPORTED A FEVER OF 104.0 FAHRENHEIT AND WAS GOING TO THE HOSPITAL. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PA STATED MANY TESTS AND CULTURES WERE PERFORMED. RESULTS NOT PROVIDED. ON (B)(6) 2009, THE PA REPORTED NOT KNOWING IF THE PATIENT WAS STILL HOSPITALIZED AND NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 8095

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization