BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1503819 · Received October 8, 2009

    Report

    Report Number
    2032896-2009-00024
    Event Type
    Other
    Date Received
    October 8, 2009
    Date of Event
    September 25, 2009
    Report Date
    October 7, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P0040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)#: P020023. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNK. WHEN ASKED IF THERE WAS A RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENTS, THE PHYSICIAN STATED "ABSOLUTELY."

    Description of Event or Problem · 1

    ON 09/28/2009, A SPONTANEOUS REPORT BY A PHYSICIAN WAS REC'D FROM A COMPANY REP REGARDING A (B) (6) FEMALE WHO REC'D AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED NO ALLERGIES AND NO PREVIOUS TREATMENT WITH EITHER RESTYLANE OR PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT REC'D A 0.5 CC INJECTION OF RESTYLANE ON (B) (6) 2009 BILATERALLY TO THE NASOLABIAL FOLDS. PRE-PROCEDURE MEDICATIONS INCLUDED PREPARATION OF THE NASOLABIAL FOLDS WITH ALCOHOL FOLLOWED BY BETADINE (POVIDONE-IODINE) AND INJECTABLE XYLOCAINE (LIDOCAINE HYDROCHLORIDE) APPLIED LOCALLY TO THE IMPLANT AREAS. NO TOPICAL ANESTHETICS WERE USED. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B) (6) 2009, WITHIN 24 HRS OF IMPLANTATION, THE PT DEVELOPED AN ABSCESS WITH REDNESS AND SWELLING OF THE LEFT NASOLABIAL FOLD. ON (B) (6) 2009, THE ABSCESS WAS LANCED AND THE PUS WAS CULTURED. THE CULTURE RESULTS CAME BACK AS POSITIVE FOR COAGULASE-NEGATIVE STAPHYLOCOCCUS (REPORTED AS "STAPH COAGULASE NEGATIVE"), SENSITIVE TO CIPRO (CIPROFLOXACIN). THE PHYSICIAN DIAGNOSED THE PT WITH A BACTERIAL ABSCESS. TREATMENT CONSISTENT OF CIPRO 500 MG TWICE DAILY FOR 10 DAYS AND THE PHYSICIAN ALSO ADMINISTERED ANCEF (CEFAZOLIN) 1 GRAM INTRAMUSCULARLY. THE PHYSICIAN SAW THE PT ON (B) (6) 2009, AND NOTED THAT THE ABSCESSED AREA WAS STILL SYMPTOMATIC WITHOUT MUCH IMPROVEMENT. ON (B) (6) 2009, THE PT DEVELOPED ANOTHER ABSCESS BELOW THE FIRST ABSCESS IN THE MARIONETTE REGION. THE SECOND ABSCESS WAS ALSO LANCED AND THE PUS DRAINAGE WAS SENT FOR A CULTURE. THE RESULTS WERE NOT AVAILABLE, BUT THE PHYSICIAN PRESUMED THE RESULTS WOULD BE THE SAME AS THE FIRST ABSCESS. THE PT WAS SCHEDULED FOR FOLLOW-UP IN THE PHYSICIAN'S OFFICE ON (B) (6) 2009. ADD'L INFO 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 62 YR