BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERLANE-L INJECTABLE GEL

    MDR report key: 2650427 · Received July 2, 2012

    Report

    Report Number
    2032896-2012-00020
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 19, 2012
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINIC PHYSICIAN'S OPINION OF CAUSALITY WAS THAT THE EVENTS WERE RELATED TO THE TREATMENT AND THE PATIENT'S INABILITY TO LIFT THE RIGHT CHEEK WHEN SMILING WAS DUE TO ZYGOMATIC NERVE COMPRESSION FROM THE PERLANE-L TREATMENT. THE RN ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE FOR PERLANE-L WERE 11370 AND 2014, RESPECTIVELY; THE CLINIC DOES NOT RECORD THE EXPIRY MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON 06/19/2012, A SPONTANEOUS REPORT BY A REGISTERED NURSE (RN) WAS RECEIVED FROM A COMPANY REPRESENTATIVE VIA FAX REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). ADDITIONAL INFORMATION WAS RECEIVED 06/22/2012 FROM THE RN. BASED ON THE INFORMATION RECEIVED, THE CASE WAS UPGRADED TO UNEXPECTED SEVERITY. MEDICAL HISTORY, PATIENT SKIN TYPE, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED A 2 CC INJECTION OF PERLANE (SYRINGE SIZE NOT REPORTED) ON AN UNKNOWN DATE TO THE NASOLABIAL FOLDS AND MID FACE. PRE-PROCEDURE MEDICATIONS WERE NOT REPORTED. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF THE IMPLANTATION INCLUDED INJECTION OF DYSPORT (ABOBOTULINUMTOXINA) 85 UNITS TO THE GLABELLA AND LATERAL EYES. ON AN UNKNOWN DATE, AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED A "LOSE" OF UPPER LIP ON RIGHT SIDE OF FACE. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED. COMPANY COMMENT: "LOSE OF UPPER LIP ON RIGHT SIDE OF FACE" IS ASSESSED AS CUSTOMER DISSATISFACTION, WHICH IS NOT AN ADVERSE EVENT. ON 06/22/2012, ADDITION INFORMATION WAS RECEIVED FROM THE RN. THE EVENT OF MEDICAL DEVICE IMPLANTATION WAS REPLACED WITH THE EVENT OF NERVE COMPRESSION. THE OVERALL CASE ASSESSMENT WAS UPGRADED TO UNEXPECTED SEVERITY. THE RN CONFIRMED THE PRODUCT TO BE PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3 PERCENT LIDOCAINE), NOT PERLANE AS WAS PREVIOUSLY REPORTED. MEDICAL HISTORY INCLUDED SUN SPOTS ON FACE, NO PREVIOUS TREATMENT WITH DERMAL FILLERS, AND WAS REPORTED AS OTHERWISE HEALTHY. CONCOMITANT MEDICATIONS INCLUDED HYDROQUINONE TOPICALLY FOR SUN SPOTS ON FACE. THE PATIENT RECEIVED A 2 CC INJECTION OF PERLANE-L FROM A 2 CC SYRINGE ON (B)(6) 2012 TO THE BILATERAL NASOLABIAL FOLDS AND MALAR AREAS (PREVIOUSLY REPORTED AS MID FACE). PRE-PROCEDURE MEDICATIONS WERE NOT REPORTED. THE RN CONFIRMED THAT ADDITIONAL PROCEDURES PERFORMED AT TIME OF IMPLANTATION INCLUDED DYSPORT 85 UNITS TO THE GLABELLA AND LATERAL EYES AND REPORTED THAT THE CLINIC PHYSICIAN DID NOT BELIEVE THE PATIENT'S SYMPTOMS WERE DUE TO THE DYSPORT INJECTION. ON AN UNSPECIFIED DATE IN (B)(6) 2012, AFTER THE IMPLANTATION, THE PATIENT DEVELOPED SWELLING UNDER BOTH EYES AND UPPER CHEEKS. ON (B)(6) 2012, THE PATIENT WAS EVALUATED BY THE CLINIC PHYSICIAN WHO NOTED THE SWELLING AND BELIEVED IT WAS JUST NORMAL POST INJECTION SWELLING; THE PATIENT HAD NO OTHER SYMPTOMS AT THE TIME OF THE VISIT. ON (B)(6) 2012, THE PATIENT CALLED THE CLINIC TO REPORT THAT WHEN SHE WOKE UP THAT MORNING, WHEN SHE SMILED SHE COULD NOT LIFT HER RIGHT CHEEK. ON (B)(6) 2012, THE PATIENT WAS SEEN BY THE CLINIC PHYSICIAN WHO NOTED ASYMMETRY WHEN THE PATIENT SMILED AND THAT THE PATIENT'S RIGHT CHEEK DID NOT LIFT WHILE SMILING. THE CLINIC PHYSICIAN BELIEVED IT WAS DUE TO THE SWELLING, PRESCRIBED ORAL PREDNISONE, AND INSTRUCTED THE PATIENT TO APPLY ICE PACKS. ON (B)(6) 2012, THE RN CALLED THE PATIENT; THE PATIENT COULD NOT LIFT HER RIGHT CHEEK WHEN SHE SMILED. ON (B)(6) 2012, THE PATIENT'S SYMPTOMS CONTINUED AND SHE WAS SEEN BY THE CLINIC PHYSICIAN. THE CLINIC PHYSICIAN BELIEVED THAT THE PERLANE-L TREATMENT HAD CAUSED ZYGOMATIC NERVE COMPRESSION IN THE RIGHT CHEEK. THE PATIENT WAS TREATED WITH A 0.05 (UNITS NOT REPORTED) INJECTION OF HYALURONIDASE TO THE RIGHT CHEEK AREA. THE SWELLING UNDER THE PATIENT'S EYES HAD IMPROVED AND SHE JUST HAD SLIGHT SWELLING TO THE AREA UNDER THE RIGHT EYE NEAR THE NOSE. ON (B)(6) 2012, THE PATIENT WAS SEEN BY THE CLINIC PHYSICIAN AND THERE WAS NO IMPROVEMENT; THE PATIENT STILL COULD NOT LIFT THE RIGHT CHEEK WHEN SHE SMILED. THE PATIENT WAS INJECTED WITH 0.06 CC OF HYALURONIDASE TO THE RIGHT CHEEK AND 0.02 CC OF HYALURONIDASE TO THE LEFT CHEEK TO "EVEN THINGS OUT." NO IMMEDIATE IMPROVEMENT WAS OBSERVED WHEN THE PATIENT LEFT THE CLINIC; SHE WAS STILL UNABLE TO LIFT THE RIGHT CHEEK WHEN SMILING. AS OF (B)(6) 2012, THE RN CONFIRMED THAT THE PATIENT WAS UNABLE TO LIFT THE RIGHT CHEEK WHEN SHE SMILED, WHEN THE PATIENT SMILED ASYMMETRY WAS NOTED, WHEN THE PATIENT WAS NOT SMILING THERE WAS NO ASYMMETRY NOTED, NO TESTING HAD BEEN PERFORMED, AND A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERLANE-L INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB 11370

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR