BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE-L INJECTABLE GEL

    MDR report key: 2273580 · Received September 22, 2011

    Report

    Report Number
    2032896-2011-00056
    Event Type
    Other
    Date Received
    September 22, 2011
    Date of Event
    April 29, 2011
    Report Date
    September 13, 2011
    Manufacturer
    A - MED AB.
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENT: "WAS UNHAPPY WITH THE RESULTS" IS ASSESSED AS CUSTOMER DISSATISFACTION WHICH IS NOT AN ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A SPONTANEOUS REPORT WAS RECEIVED FROM A REGISTERED NURSE REGARDING A (B)(6), FEMALE, WHO RECEIVED AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). MEDICAL HISTORY INCLUDED BREAST SURGERY ON AN UNSPECIFIED DATE IN (B)(6) 2008; UNSPECIFIED MEDI-SPA TREATMENTS ON UNK DATES (REPORTED AS "(OFF AND ON SINCE (B)(6) 2009"); PREVIOUS INJECTIONS OF JUVEDERM (ACROSS-LINKED HYALURONIC ACID DERMAL FILLER) ON UNK DATES (REPORTED AS "PRIOR TO (B)(6) 2010"); PREVIOUS 1 CC INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) AND PREVIOUS 1 CC INJECTION OF JUVEDERM ON (B)(6) 2010 TO THE ORAL COMMISSURES; PREVIOUS 1 CC INJECTION OF RESTYLANE-L ON (B)(6) 2010 TO THE ORAL COMMISSURES; PREVIOUS 2 CC INJECTION OF RESTYLANE-L ON (B)(6) 2011 TO THE NASOLABIAL FOLDS AND ORAL COMMISSURES AND ALLERGIES TO KEFLEX (CEPHALEXIN) AND SULFA RESULTING IN ANAPHYLAXIS/SWOLLEN EYES. THE PT'S SKIN TYPE WAS FITZPATRICK III-IV. CONCOMITANT MEDICATIONS INCLUDED UNSPECIFIED HORMONE REPLACEMENT THERAPY, BUTALBITAL, AND UNSPECIFIED "HERBALS" (NO DOSAGES FOR THE PT'S CONCOMITANT MEDICATIONS WERE INDICATED IN THE PT'S CHART). THE PT RECEIVED A 1 CC INJECTION OF RESTYLANE-L ON (B)(6) 2011 TO THE ORAL COMMISSURES (0.5 CC) AND NASOLABIAL FOLDS (0.5 CC) VIA THREADING INJECTION TECHNIQUE. PRE-PROCEDURE MEDICATIONS INCLUDED APPLICATION OF TOPICAL BLT (BETACAINE, LIDOCAINE AND TETRACAINE) AND ICE WAS ALSO APPLIED PRIOR TO THE IMPLANTATION. ADD'L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED A 58 UNITS INJECTION OF BOTOX (ONABOTULINUMTOXINA) TO THE FOREHEAD (13 UNITS), GLABELLA (20 UNITS), AND CROW'S FEET (25 UNITS). ON (B)(6) 2011, AFTER THE IMPLANTATION, THE PT PRESENTED TO THE INJECTING CLINIC TO REPORT SHE WAS UNHAPPY WITH THE RESULTS OF THE RESTYLANE-L TREATMENT; NO ADVERSE REACTION WAS NOTED. ON (B)(6) 2011, THE PT WAS EVALUATED BY A PHYSICIAN FROM THE INJECTING CLINIC AND WAS NOTED TO HAVE SIGNIFICANT INFLAMMATION OF THE ORAL COMMISSURES (RIGHT SIDE MORE INFLAMED THAN THE LEFT). AN INCISION AND DRAINAGE OF THE BILATERAL ORAL COMMISSURES WAS PERFORMED. THE DRAINAGE WAS CULTURED AND THE PT WAS DIAGNOSED WITH STERILE ABSCESSES TO THE BILATERAL ORAL COMMISSURES. THE ORAL COMMISSURES WERE INJECTED WITH HYALURONIDASE. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. THE ORAL COMMISSURES WERE AGAIN INCISED AND DRAINED. THE PT WAS PRESCRIBED ORAL CLINDAMYCIN (DOSE UNK) FOR THE INFECTION. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. THE ORAL COMMISSURES, WHICH WERE RED AND SWOLLEN, WERE AGAIN INCISED AND DRAINED. THE PT WAS INSTRUCTED TO APPLY WARM SOAKS TO THE ORAL COMMISSURES THREE TIMES DAILY AND NOTIFY THE CLINIC IF THERE WERE ANY NEGATIVE SIDE EFFECTS. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. IMPROVEMENT OF THE REDNESS, SWELLING AND TENDERNESS WAS NOTED. A SMALL NODULE WAS NOTED ON THE RIGHT ORAL COMMISSURE WHICH WAS NOT OF CONCERN, AS THE PHYSICIAN FELT IT WAS A LUMP OF RESTYLANE. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. THE INFECTION HAS RESOLVED. AT THIS VISIT, THE PT REQUESTED MORE TREATMENT WITH RESTYLANE-L; THE PHYSICIAN RECOMMENDED THE PT WAIT UNTIL ALL THE BUMPS WERE GONE BEFORE RECEIVING ANY FURTHER RESTYLANE-L INJECTIONS. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. THE SAME NODULE ON RIGHT SIDE OF ORAL COMMISSURES WAS NOTED. MORE HYALURONIDASE WAS INJECTED AND THE PT WAS INSTRUCTED TO MASSAGE THE AREA. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. A SMALL BUMP ON THE RIGHT SIDE OF THE ORAL COMMISSURES WAS AGAIN NOTED. ON (B)(6) 2011, THE PT WAS EVALUATED AT THE INJECTING CLINIC. NO RESTYLANE-L REMAINED IN THE ORAL COMMISSURES; THE ABSCESS HAD HEALED COMPLETELY; AND NO SCAR TISSUE WAS NOTED. THE PHYSICIAN REQUESTED ADD'L INFO TO DETERMINE IF THE PT WAS A CANDIDATE FOR RESTYLANE-L, AS THE PT HAD AGAIN REQUESTED ANOTHER INJECTION OF RESTYLANE-L. NO FURTHER INFO WAS AVAILABLE. THE REGISTERED NURSE STATED THE EVENTS WERE RELATED TO THE RESTYLANE-L TREATMENT. THE REGISTERED NURSE ASSESSED THE SEVERITY OF THE EVENTS AS SEVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE-L INJECTABLE GEL INJECTABLE DERMAL FILLER LMH A - MED AB. 10717

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R JUVEDERM (PREV.)| UNSPECIFIED HORMONE| JUVEDERM (PREV.)| REPLACEMENT THERAPY: BUTALBITAL (CON.)| RESTYLANE-L (PREV.)| UNSPECIFIED HERBALS (CON.)| RESTYLANE-L (PREV.)| RESTYLANE (PREV.)