BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1944585 · Received December 22, 2010

    Report

    Report Number
    2032896-2010-00045
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 15, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K): P040024.

    Description of Event or Problem · 1

    ON DECEMBER 15, 2010, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A PHYSICIAN REGARDING A FEMALE (AGE REPORTED AS "IN HER 50'S;" DATE OF BIRTH NOT REPORTED) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). MEDICAL HISTORY INCLUDED NO ALLERGIES, NO UNDERLYING MEDICAL CONDITIONS AND NO PREVIOUS DERMAL FILLER INJECTIONS OR AESTHETIC PROCEDURES. THE PT'S SKIN TYPE WAS WHITE. THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT RECEIVED A 1CC INJECTION OF RESTYLANE AND A 1CC INJECTION OF PERLANE-L ON (B)(6) 2010 TO THE NASOLABIAL FOLDS (0.25CC TO EACH NASOLABIAL FOLD), LIPS COMMISSURES AND "THUMB PRINTS" (1.5 CC INTO THE LIPS IN THE AREA FROM THE LIPS TO CHIN). PRE-PROCEDURE MEDICATION INCLUDED A DENTAL BLOCK WITH CARBOCAINE (MEPIVACAINE). NO ADD'L PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. THE IMPLANTATION WAS PERFORMED AT THE INJECTING PHYSICIAN'S HOME. ON (B)(6) 2010, FIVE DAYS AFTER THE IMPLANTATION, THE PT DEVELOPED A COLD SORE ON HER LEFT UPPER LIP AND ANOTHER COLD SORE RIGHT BELOW HER LIP IN THE CHIN AREA. THE PT HAD NEVER HAD COLD SORES BEFORE AND THEREFORE, DID NOT THINK THESE WERE COLD SORES. ON (B)(6) 2010, THE INJECTING PHYSICIAN EVALUATED THE PT AND FELT THAT THE PT HAD COLD SORES AND PRESCRIBED VALTREX (VALACYCLOVIR HYDROCHLORIDE). THE INJECTING PHYSICIAN ALSO NOTED THAT THE PT HAD DEVELOPED A SMALL LUMP/SWELLING TO THE LEFT NASOLABIAL FOLD. THE LUMP/SWELLING WAS NOT RED OR TENDER THEREFORE, NO TREATMENT WAS PRESCRIBED. THE LUMP/SWELLING TO THE LEFT NASOLABIAL FOLD STARTED TO INCREASE IN SIZE AND BECAME RED AND TENDER A FEW DAYS BEFORE THE PT WAS SEEN AGAIN BY THE INJECTING PHYSICIAN ON (B)(6) 2010. THE PT PRESENTED WITH SWELLING, TENDERNESS, REDNESS AND AN APPROX 1.5 CM LUMP TO THE LEFT NASOLABIAL FOLD. THE PT REPORTED TO THE INJECTING PHYSICIAN THAT THE LUMP HAD BEEN DRAINING A CLEAR, BLOOD-TINGED FLUID FOR A FEW DAYS; HOWEVER, THE INJECTING PHYSICIAN DID NOT VISUALIZE ANY DRAINAGE. DUE TO THE SIZE OF THE LUMP/SWELLING, REDNESS, TENDERNESS AND THE PT'S REPORT OF DRAINAGE, THE INJECTING PHYSICIAN FELT THE PT HAD DEVELOPED AN ABSCESS. THE INJECTING PHYSICIAN PRESCRIBED KEFLEX (CEPHALEXIN) FOR THE ABCESS. THE PT WAS EVALUATED AGAIN BY THE INJECTING PHYSICIAN ON (B)(6) 2010 AT WHICH TIME THE ABSCESS WAS MUCH IMPROVED. THE SIZE OF THE ABSCESS WAS REDUCED BY MORE THAN HALF OF THE SIZE IT WAS AT THE PT'S PRIOR VISIT ON (B)(6) 2010. THE REDNESS AND TENDERNESS WERE MORE THAN 60% IMPROVED AND NO DRAINAGE WAS NOTED. THE COLD SORE ON THE PT'S UPPER LEFT LIP WAS SWOLLEN. THE INJECTING PHYSICIAN PALPATED THE AREA AND NOTED A FLUID-FILLED LUMP LESS THAN 1 CM IN SIZE. NO DRAINAGE WAS NOTED. THE INJECTING PHYSICIAN FELT THIS WAS ANOTHER ABSCESS THAT HAD DEVELOPED. THE COLD SORE TO THE CHIN AREA HAD IMPROVED. THE PT'S SYMPTOMS WERE IMPROVING SLOWLY WITH TIME. AS OF (B)(6) 2010, THE PT HAD FINISHED BOTH THE VALTREX AND KEFLEX (7 DAY COURSE). THE INJECTING PHYSICIAN OPTED NOT TO RESUME TREATMENT AT THAT TIME, BUT ADVISED THE PT TO CALL IF HER SYMPTOMS WORSENED OR DID NOT CONTINUE TO IMPROVE. AS OF DECEMBER 17, 2010, THE INJECTING PHYSICIAN HAD NOT SEEN OR SPOKEN TO THE PT SINCE (B)(6) 2010 AND THE PT HAD NO F/U APPOINTMENTS SCHEDULED. THE INJECTING PHYSICIAN FELT THE PT GOT THE COLD SORE AS A REACTION TO THE TRAUMA AROUND THE MOUTH FROM THE INJECTION. THE LITTLE LUMP BY THE LEFT NASOLABIAL FOLD WAS A REACTION TO EITHER RESTYLANE OR PERLANE-L. THE INJECTING PHYSICIAN ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS SEVERE. THE INJECTING PHYSICIAN FELT THE EVENTS WEREN'T SEVERE IN TERMS OF BEING LIFE-THREATENING, BUT SEVERE BECAUSE "THE PT LOOKED LIKE A MESS FOR TWO WEEKS." THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE WERE 10393 AND NOVEMBER 2012, RESPECTIVELY. THE LOT NUMBER AND EXPIRATION DATE FOR PERLANE-L WERE 10514 AND JULY 2011, RESPECTIVELY. THE OTHER SUSPECT MEDICAL DEVICE IDENTIFIED IN THIS REPORT. PERLANE-L, HAS BEEN REPORTED AS MDR# 2032896-2010-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB 10393

    Patients

    Seq Age Sex Outcome Treatment
    1