BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1368456 · Received April 23, 2009

    Report

    Report Number
    2032896-2009-00004
    Event Type
    Other
    Date Received
    April 23, 2009
    Date of Event
    January 14, 2009
    Report Date
    April 22, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K)#: P020023.

    Description of Event or Problem · 1

    ON 04/13/2009, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B)(6) MALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED A BROKEN NOSE (DATE OF FRACTURE NOT REPORTED), COLD SORES, AND PREVIOUS RESTYLANE IMPLANTATION WITHOUT INCIDENT ON AN UNSPECIFIED DATE IN (B)(6)2007 TO THE LEFT SIDE AND TOP OF HIS NOSE. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. HE RECEIVED A 1 ML INJECTION OF RESTYLANE ON (B)(6)2009 TO THE LEFT SIDE AND TOP OF HIS NOSE. THE PATIENT DID NOT RECEIVE ANY PRE-PROCEDURE MEDICATIONS AND NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6)2009, AFTER IMPLANTATION, THE PATIENT DEVELOPED SLIGHT BRUISING TO THE INJECTION SITE. THE FOLLOWING DAY THE INJECTION SITE WAS ACHY AND, ON (B)(6)2009, THE PATIENT REPORTED THAT HIS NOSE WAS BRIGHT RED, OOZING PUS, AND WAS VERY SORE. HE WAS SEEN BY A PHYSICIAN ON (B)(6)2009 AND WAS DIAGNOSED WITH A PROBABLE STAPH INFECTION. THE PHYSICIAN DEBRIDED THE AREA AND PRESCRIBED ORAL CEPHALEXIN 750 MG TWICE DAILY AND TOPICAL NEOSPORIN (BACITRACIN, NEOMYCIN, AND POLYMYXIN B). A CULTURE OF THE PUS DRAINAGE WAS PERFORMED WHICH YIELDED NORMAL RESULTS. BY (B)(6)2009, THE PATIENT'S INFECTION WAS IMPROVED AND HE CONTINUED TREATMENT WITH CEPHALEXIN AND NEOSPORIN. BY (B)(6)2009, THE INFECTION HAD HEALED AND A SMALL AREA OF DEPRESSION/IMMATURE SCARRING AND SUPERFICIAL ANGIOMAS ON THE NASAL DORSUM WERE NOTED. DUE TO THE PATIENT'S HISTORY OF COLD SORES, THE PHYSICIAN SUSPECTED THAT HE MAY HAVE HAD A "REACTION TO THE HERPES VIRUS'. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 8198

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR