BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2210127 · Received August 4, 2011

    Report

    Report Number
    2032896-2011-00042
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 27, 2011
    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

    ADDITIONAL PMA/510(K) #: P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2011, 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 PREVIOUS INJECTION OF BOTOX (ONABOTULINUMTOXINA) ON AN UNKNOWN DATE; NO PREVIOUS INJECTION OF RESTYLANE AND NO KNOWN DRUG ALLERGIES (NKDA); THE PATIENT'S MEDICAL HISTORY WAS OTHERWISE UNREMARKABLE. THE PATIENT'S SKIN TYPE WAS REPORTED AS "OLIVE." THE PATIENT WAS NOT TAKING CONCOMITANT PRESCRIPTION MEDICATIONS OR SUPPLEMENTS. THE PATIENT RECEIVED "10-12" INJECTIONS OF RESTYLANE (SYRINGES SIZES AND AMOUNT INJECTED WERE UNKNOWN) ON (B)(6) 2011 TO ABOVE THE EYEBROWS, ACROSS THE FOREHEAD. THE PATIENT DID NOT RECEIVED ANY PRE-PROCEDURE MEDICATIONS. COLD PACKS WERE APPLIED TO THE SKIN PRIOR TO THE INJECTIONS. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2011, AFTER THE IMPLANTATION, THE PATIENT DEVELOPED VISION LOSS IN HIS LEFT EYE, FURTHER DESCRIBED BY THE PATIENT AS "ONLY HAD VISION AND COULD SEE THINGS IN ONE CORNER OF THE VISUAL FIELD; THE REMAINING VISUAL FIELD WAS DARK." ON (B)(6) 2011, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND THE PRESSURES IN HIS EYES WERE MEASURED AS NORMAL. THE EVALUATING EMERGENCY ROOM HEALTHCARE PROVIDER RECOMMENDED THAT THE PATIENT SEE AN EYE SPECIALIST, AS THE HOSPITAL DID NOT HAVE AN OPHTHALMOLOGIST IN HOUSE. THE PATIENT WAS RELEASED TO HOME AFTER 4-5 HOURS. ON (B)(6) 2011, THE PATIENT WAS EVALUATED BY AN OPHTHALMOLOGIST WHO DIAGNOSED THE PATIENT WITH "BRANCH RETINAL ARTERY OCCLUSION." THE OPHTHALMOLOGIST PRESCRIBED ASPIRIN 81 MG ONCE DAILY AND ADVISED THERE WAS NOTHING ELSE THAT COULD BE DONE. ON UNSPECIFIED DATES IN (B)(6) 2011, FOLLOWING THE PATIENT'S EVALUATION WITH THE OPHTHALMOLOGIST, THE PATIENT REPORTED HE HAD SEEN SEVERAL OTHER UNSPECIFIED HEALTH CARE PROVIDERS, INCLUDING THE INJECTING PHYSICIAN, WHO ADVISED HE WAS GOING TO INQUIRE ABOUT TREATMENT WITH HYALURONIDASE. THE PATIENT FURTHER REPORTED THAT AFTER 3 WEEKS HE DID NOT RECEIVE AN ANTICIPATED FOLLOW-UP CALL FROM THE INJECTING PHYSICIAN. ON AN UNSPECIFIED DATE DURING THE WEEK OF (B)(6) 2011, THE PATIENT WENT BACK TO THE INJECTING CLINIC TO RETRIEVE HIS MEDICAL RECORDS, WHICH THE CLINIC REFUSED TO RELEASE. AS OF (B)(6) 2011, THE PATIENT'S EVENTS WERE ONGOING. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT'S OPHTHALMOLOGIST. COMPANY COMMENT: THE EVENTS HAVE NOT BEEN MEDICALLY CONFIRMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other CON MEDS =NONE| BOTOX (PREV.)