BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1032475 · Received April 18, 2008

    Report

    Report Number
    9710154-2008-00006
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    February 27, 2008
    Report Date
    April 17, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESTYLANE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS 9127 AND 01/2010. ADDITIONAL PMA/510(K) NUMBER: P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT (HERPES ZOSTER) IS BEING SUBMITTED AS A 10-DAY REPORT. A HEALTH CARE PROVIDER REPORTED THAT A (B) (6) FEMALE PT RECEIVED INJECTIONS OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO ACNE SCARS ON THE GLABELLA, CHIN AND LEFT CHEEK ON (B) (6) 2008. ANESTHESIA PRE PROCEDURE INCLUDED AN UNSPECIFIED TOPICAL. THE PT HAD NO SIGNIFICANT MEDICAL HISTORY. THE PT WAS NOT TAKING CONCOMITANT MEDICATIONS. ON (B) (6) 2008, THE PT EXPERIENCED BLACK AND BLUE, RED SWOLLEN AND PAIN IN THE GLABELLA AREA. THE AREA ALSO HAD SMALL WHITEHEADS WITH PUS. ON (B) (6) 2008, THE PT WAS EXAMINED BY THE CALLER AND REFERRED TO HER PHYSICIAN AS THE CALLER BELIEVED THE SYMPTOMS TO BE SHINGLES. ON (B) (6) 2008, THE PT WAS EXAMINED BY HER PHYSICIAN AND DIAGNOSED WITH SHINGLES AND HAD A VIRAL CULTURE TAKEN. THE PT WAS PRESCRIBED VALTREX (VALACYCLOVIR HCL) AND A CULTURE WAS DONE. THE PT TREATED THE AREA WITH ICE FOR A "FEW DAYS". ON (B) (6) 2008, THE PT WAS SEEN BY THE PHYSICIAN WHO INDICATED PROGRESS TOWARD IMPROVEMENT. ON (B) (6) 2008, THE PT STATED HER CONDITION WAS THE SAME AND HAD DEVELOPED NEW LARGE PIMPLES IN THE GLABELLA AREA. THE PHYSICIAN NOW DIAGNOSED THE SYMPTOMS AS A BACTERIAL INFECTION AND PRESCRIBED ZITHROMAX (AZITHROMYCIN). BACTROBAN OINTMENT (MUPIROCIN) WAS ALSO PRESCRIBED. ON AN UNSPECIFIED DATE, THE RESULTS OBTAINED FROM THE VIRAL CULTURE RESULTED IN NO VIRUS ISOLATED. (IT TOOK 3.5 WEEKS TO GET THE RESULTS). ON (B) (6) 2008, THE PT WAS SEEN BY THE CALLER WHO REPORTED AN AREA OF 1 INCH BY 1/3 INCH STILL RED AND HAS ONE SMALL SCAB IN THE GLABELLA AREA. ON (B) (6) 2008, ADDITIONAL INFO RECEIVED WAS THAT THE SYMPTOMS ARE NOW DIAGNOSED AS AN ISCHEMIC EVENT. THE PT WAS INSTRUCTED TO APPLY WARM COMPRESSES TO THE AREA, WASH WITH CETAPHIL CONTINUE WITH BACTROBAN AND FOLLOW UP IN A WEEK. ON (B) (6) 2008, THE PT PRESENTED HERSELF (WITH A NEW PUSTULE) TO A PLASTIC SURGEON THAT "POPPED" THE PUSTULE AND RULED OUT A VASCULAR EVENT. ON (B) (6) 2008, ADDITIONAL INFO WAS RECEIVED THAT THE EVENT IS DIAGNOSED AS HERPES ZOSTER (HERPES ZOSTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9127

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR