BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2061319 · Received April 11, 2011

    Report

    Report Number
    2032896-2011-00022
    Event Type
    Other
    Date Received
    April 11, 2011
    Date of Event
    June 1, 2010
    Report Date
    April 1, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L: P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A SPONTANEOUS REPORT BY A CLINIC MANAGER WAS RECEIVED FROM A COMPANY REPRESENTATIVE VIA ANOTHER MANUFACTURER (REFERENCE NUMBER (B)(4)) REGARDING A (B)(6)-OLD FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED PREVIOUS INJECTION OF BOTOX (ONABOTULINUMTOXINA) WITH NO PROBLEMS; ALLERGIES TO POLLEN AND AN ALLERGY TO HYDROCODONE (PER THE CLINIC MANAGER) AND NO KNOWN DRUG ALLERGIES (NKDA) (PER THE PATIENT). THE PATIENT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS INCLUDED ESTRADIOL. THE PATIENT RECEIVED A 1.0 ML INJECTION OF RESTYLANE ON (B)(6) 2010 AROUND THE MOUTH. PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED TOPICAL NUMBING AGENT (PER THE PATIENT) AND NO PRE-PROCEDURE MEDICATION (PER THE CLINIC MANAGER). ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED AN 80 UNIT INJECTION OF DYSPORT (ABOBOTULINUMTOXINA) TO THE FOREHEAD/FRONTALIS (70 UNITS) AND AROUND THE MOUTH (10 UNITS). ON AN UNSPECIFIED DATE IN (B)(6) 2010, APPROXIMATELY 1 WEEK AFTER THE INJECTION, THE PATIENT DEVELOPED EXTREME DRYNESS OF HER MOUTH AT NIGHT; THE PATIENT WOULD WAKE UP WITH HER TONGUE HANGING OUT OF HER MOUTH AND HAD DIFFICULTY SWALLOWING BECAUSE HER MOUTH WAS SO DRY. THE PATIENT DRANK 2 GLASSES OF WATER WITH RESOLUTION OF THESE SYMPTOMS. THE PATIENT ADDITIONALLY DEVELOPED BURNING OF THE KNEES, HEADACHES AND MUSCLE ACHES/PAINS ALL OVER HER BODY, INCLUDING BACK AND SHOULDERS, WHICH FELT LIKE ARTHRITIC PAIN. THE PATIENT SELF TREATED HER PAIN AND HEADACHES WITH TYLENOL (ACETAMINOPHEN). ON UNSPECIFIED DATES IN 2010, THE PATIENT HAD SEEN AND SPOKEN TO A PHYSICIAN SEVERAL TIMES FOR THE REPORTED EVENTS. ON AN UNSPECIFIED DATE IN 2010, UNSPECIFIED BLOOD WORK WAS PERFORMED, WHICH INCLUDED A TEST FOR LUPUS, WHICH WAS NORMAL. ACCORDING TO THE PATIENT, THE PHYSICIAN THOUGHT THAT THE PATIENT'S SYMPTOMS MAY HAVE BEEN RELATED TO AN UNSPECIFIED MEDICATION THAT THE PATIENT WAS TAKING AND THE PATIENT WAS ADVISED TO DISCONTINUE TREATMENT WITH THE MEDICATION. ON UNSPECIFIED DATES IN 2010, THE PATIENT WAS TREATED WITH AN INJECTION OF CORTISONE AND PHYSICAL THERAPY. ON (B)(6) 2010, THE PATIENT REPORTED THESE EVENTS TO THE INJECTING NURSE PRACTITIONER AND CLINIC MANAGER VIA TELEPHONE. AT THE TIME OF HER CALL, THE PATIENT REFUSED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE CURRENT STATUS OF HER SYMPTOMS OR ANY FURTHER DETAILS OF HER MEDICAL EVALUATIONS. AS OF (B)(6) 2010, THE PATIENT'S SYMPTOMS WERE ONGOING. THE CLINIC MANAGER DID NOT COMMENT ON THE CAUSALITY OR SEVERITY OF THE REPORTED EVENTS. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED. COMPANY COMMENT: THE PATIENT RECEIVED BOTH DYSPORT AND RESTYLANE. UNABLE TO ASSESS CAUSALITY OF THE EVENTS TO TREATMENT.

    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 66 YR ESTRADIOL (CON.)| BOTOX (PREV.)