BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1613179 · Received February 12, 2010

    Report

    Report Number
    2032896-2010-00004
    Event Type
    Other
    Date Received
    February 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 11, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) # P020023. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(4) 2010, A SPONTANEOUS REPORT WAS RECEIVED FROM A CLINIC "DIRECTOR OF DEVELOPMENT" REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). ADDITIONAL INFO WAS RECEIVED FROM THE INJECTING PHYSICIAN ON (B)(6) 2010. MEDICAL HISTORY INCLUDED ALLERGIES TO PENICILLIN (REPORTED AS "PCN") AND DEMEROL (MEPERIDINE), A KIDNEY REMOVED (1970), (B)(6), PREVIOUS INJECTION OF RESTYLANE ON AN UNSPECIFIED DATE "SEVERAL YEARS AGO" AND NO PREVIOUS INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). THE PT'S SKIN TYPE WAS DESCRIBED AS VERY WHITE, VERY FAIR SKIN. CONCOMITANT MEDICATIONS INCLUDED PREMARIN (CONJUGATED ESTROGENS) 0.625 MG ONCE A DAY, LUNESTA (ESZOPICLONE) 2 MG AS NEEDED FOR SLEEP, NEURONTIN (GABAPENTIN) 600 MG ONCE A DAY, ASPIRIN (ACETYLSALICYLIC ACID) (REPORTED AS "ASA") 81 MG ONCE A DAY, VALTREX (VALACYCLOVIR HYDROCHLORIDE) 500 MG ONCE A DAY, DETROL (TOLTERODINE TARTRATE) 4 MG ONCE A DAY, CRANBERRY CAPSULES 3 TIMES A DAY, CALCIUM 2 TIMES A DAY, "ULTI-VITA" ONCE A DAY, ESTER C (VITAMIN C AND CALCIUM ASCORBATE) ONCE A DAY, VITAMIN B12 ONCE A DAY, VITAMIN D ONCE A DAY AND OMEGA 3 ONCE A DAY. THE PT RECEIVED AN INJECTION OF RESTYLANE [AMOUNT BELIEVED TO BE 1 FULL SYRINGE (1 ML)] ON (B)(6) 2010 TO THE ANGLES OF HER MOUTH AND ABOVE HER LIP. PRE-PROCEDURE MEDICATION INCLUDED TOPICAL LIDOCAINE. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN (B)(6) 2010, AFTER THE IMPLANTATION, THE PT DEVELOPED INCREASED PAIN AND TENDERNESS AT THE SITE OF INJECTION. ON (B)(6) 2010, THE PT RETURNED TO THE CLINIC AND WAS EVALUATED BY THE INJECTING PHYSICIAN WHO NOTED MARKED SWELLING OF THE PERIORAL AREA WHICH APPEARED TO BE FIRM AND RED. AN EARLY ABSCESS HAD DEVELOPED ON THE PT'S UPPER LIP ALONG WITH MULTIPLE OTHER LESIONS. THE PT HAD DIMINISHED SENSATION DUE TO SWELLING AND PAIN. AN INCISION AND DRAINAGE (REPORTED AS "I&D") WAS PERFORMED AT THE CLINIC AND A BIOPSY WAS TAKEN. THE RESULTS OF THE BIOPSY WERE NEGATIVE SHOWING NO BACTERIAL GROWTH OF "ANYTHING OUT OF THE ORDINARY." THE PT'S NOSE WAS SWABBED AND THE RESULTS WERE NEGATIVE SHOWING NORMAL FLORA. THE INJECTING PHYSICIAN REFERRED THE PT TO THE HOSPITAL WITH A SURGICAL CONSULTATION FOR PRESUMED FACIAL CELLULITIS. UPON ADMISSION TO THE HOSPITAL ON (B)(6) 2010, THE PT'S WHITE BLOOD CELL COUNT (REPORTED AS "WBC") WAS 15,000 (REFERENCE RANGE NOT REPORTED). ON (B)(6) 2010, A SECOND I&D PROCEDURE AND BIOPSY WERE PERFORMED BY A PLASTIC SURGEON (RESULTS WERE REPORTED AS UNK). TREATMENT INCLUDED WARM SOAKS, TOPICAL LIDEX (FLUOCINONIDE), VARIOUS UNSPECIFIED ANTIBIOTICS AND CLOSE OBSERVATION. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2010, THE INJECTING PHYSICIAN DID NOT KNOW THE CURRENT STATUS OF THE PT, AS HE HAD NOT SPOKEN WITH HER FOR SEVERAL DAYS. TO THE PHYSICIAN'S KNOWLEDGE, THE PT WAS AT HOME RECUPERATING. THE PHYSICIAN'S DIAGNOSIS FOR THE PT'S SYMPTOMS WAS PRESUMED FACIAL CELLULITIS AND HE DID NOT KNOW IF ANY OTHER DIAGNOSES WERE GIVEN TO THE PT, AS HE HAD NOT SEEN THE HOSPITAL DISCHARGE SUMMARY. THE PHYSICIAN CONSIDERED THE POSSIBILITY OF AN INFECTION BECAUSE ALL OF THE LESIONS PRESENT WERE IN THE AREA WHERE RESTYLANE WAS INJECTED. THE PHYSICIAN BELIEVED THE PT'S SYMPTOMS WERE EITHER AN INFECTIOUS PROCESS OR A REACTION TO RESTYLANE; HE WAS UNSURE OF WHICH ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 10101

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization DETROL (TOLTERODINE TARTRATE)| LUNESTA (ESZOPICLONE)| VITAMIN D| PREMARIN (CONJUGATED ESTROGENS)| VITAMIN B12| CALCIUM| ESTER C (VITAMIN C)| CALCIUM ASCORBATE| "ULTI-VITA"| OMEGA 3| ASPIRIN (ACETYLSALICYLIC ACID)| VALTREX (VALACYCLOVIR HYDROCHLORIDE)| NEURONTIN (GABAPENTIN)| CRANBERRY CAPSULES