BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERLANE L, PERLANE

    MDR report key: 3084012 · Received April 19, 2013

    Report

    Report Number
    2032896-2013-00018
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    September 8, 2012
    Report Date
    September 14, 2012
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: (B)(4) 2013: THE EVENT RETINAL ARTERY OCCLUSION, SCOTOMA AND LOST VISION ASSESSED AS SERIOUS, UNEXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS CASE REPORT RECEIVED ON (B)(4) 2012 SENT BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED (B)(6). THE PATIENT IS ALSO AN OPHTHALMOLOGIST. THE PHYSICIAN INFORMED THAT THE PATIENT DOES NOT HAVE MEDICAL HISTORY AND HAS NOT BEEN USING ANY MEDICATION. NO HISTORY OF ALLERGIES. PREVIOUS INJECTIONS INCLUDED RESTYLANE PERLANE LIDOCAINE TO NASOLABIAL FOLDS ON AN UNKNOWN DATE, REPORTED AS 2 MONTHS AGO. ON (B)(6) 2012, PATIENT WAS INJECTED WITH RESTYLANE PERLANE LIDOCAINE 0.5 ML TO EACH NASOLABIAL FOLD WITH RETROINJECTION TECHNIQUE. THE PHYSICIAN DOES NOT HAVE THE LOT NUMBER. THIS INJECTION WAS TO COMPLETE THE PREVIOUS TREATMENT, BECAUSE THE PATIENT THOUGHT THE FIRST INJECTION WAS NOT ENOUGH. THE ADVERSE EVENT IS VISION LOST [VISUAL ACUITY REDUCED] TO THE RIGHT EYE WHERE THE PATIENT HAS THE VISION WITH A DARK PART, WHICH BEGAN ON (B)(6) 2012, 3 DAYS AFTER INJECTION. THE PHYSICIAN ASSESSMENT THE EVENT AS SERIOUS [PERMANENT IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE], BUT SHE DOES NOT BELIEVE THAT THE RELATION WITH THE APPLICATION OR WITH THE PRODUCT, BUT SHE ASKED US ABOUT THIS POSSIBILITY. THE PHYSICIAN ALSO ASKED ABOUT THE POSSIBILITY OF THROMBOEMBOLISM. REGARDING THE REACTION THE PATIENT GOT BETTER. THE PHYSICIAN BELIEVES THAT THE PATIENT MADE A DOPPLER ASSESSMENT THAT SHOWS AN OBSTRUCTION OF THE DUCT. IT WAS REQUESTED IFQ-MED AGREE THAT THIS CASE SHOULD BE CLASSIFIED AS SERIOUS, AND ALSO THE MEDICAL OPINION TO RETURN TO THE PHYSICIAN. A MEDICAL REPLY WAS SENT FROM Q-MED ON (B)(6) 2012, STATING THAT ABOUT 1 WEEK AFTER ONSET OF AE IT IS NOT POSSIBLE TO DETERMINE WHETHER THE EVENT WILL RESULT IN ANY PERMANENT FUNCTION LOSS. ALSO REFERENCE ARTICLES WERE SENT. ON (B)(6) 2012 FOLLOW UP INFORMATION WITH THE PATIENT (OPHTHALMOLOGIST) WAS RECEIVED. SHE INFORMED THAT SHE WAS NOT HOSPITALIZED AND THE VISION LOST OCCURRED ALL OF A SUDDEN ON THE RIGHT EYE ON (B)(6) 2012 (IN MEDICAL TERMS IN MEANS THAT HER VISION WAS 24/400). NEVERTHELESS, IT HAS BEEN IMPROVING AND NOW HER VISION IS 20/30. THE PATIENT INFORMED THAT SHE DID NOT HAVE ANY OTHER REACTIONS (AS PAIN, BRUISING, ETC.) DURING OR AFTER THE INJECTION. ON (B)(6) 2012, PATIENT HAD MADE A TEST CALLED ANGIOGRAPHY THAT SHOWED ARTERY OCCLUSION [RETINAL ARTERY OCCLUSION]. SINCE THEN SHE HAS BEEN USING THREE HYPOTENSIVE EYEDROP AND ANTI-INFLAMMATORY; ALP HAGAN Z, COS OPT AND NEVANAC EVERY 12 HOURS. NOW HER VISION IS 20/30. SHE WILL TRY TO SEND US THE RESULT OF THE EXAM BYE-MAIL. THE SERIOUS ASSESSMENT WAS CHANGED AND IT WAS AGREED THAT THE CASE WAS NOT SERIOUS AT THIS STAGE. ON (B)(6) 2012 ADDITIONAL INFORMATION WAS RECEIVED. THE MEDICAL PART IN (B)(4) CONTACTED THE PHYSICIAN ON (B)(4) 2012 AND INFORMED HER THAT ISN'T POSSIBLE ESTABLISH A CASUAL RELATIONSHIP BETWEEN THE SYMPTOMS OF THE PATIENT WITH THE FILLER INJECTED ON (B)(6) 2012. UNDERSCORE, VASCULAR COMPLICATIONS IS UNUSUAL AND THEY ARE DESCRIBED AFTER THE APPLICATION AS RELATED WITH TECHNICAL INJECTION. HOWEVER, DUE TO INTENSE VASCULARIZATION OF THE FACE AND ANASTOMOSES WITH THE NERVOUS SYSTEM WE COULD NOT EXCLUDE THE RISK OF A POST EMBOLISM CUTANEOUS IN SOME SITE IN THE ANATOMICAL FACE. IN THIS CASE, THE PATIENT HAD THE SYMPTOMS 4 DAYS AFTER THE APPLICATION WITH NO CONCOMITANTS SYMPTOMS. SOME STUDIES OF LITERATURE SHOW VISION LOST WITHIN 24 HOURS AFTER THE APPLICATION WITH ANOTHER SYMPTOM. THE PROPOSED REFERENCES ARTICLES WERE ALSO SENT. THE (B)(6) 2012 FOLLOW UP INFORMATION WAS RECEIVED. THE PATIENT INFORMED THAT SHE HAD A MILD IMPROVEMENT. HE VISION IS 20/40 AND SHE CONTINUES USING THE EYE DROPS. THE CASE WAS CLOSED IN (B)(6). ON (B)(6) 2012 Q-MED REQUESTED FOLLOW UP INFORMATION REGARDING THE PATIENT'S RECOVERY. ON (B)(6) 2013 LIMITED FOLLOW UP INFORMATION WAS RECEIVED. THE PATIENT INFORMED US THAT SHE DOES NOT HAVE ANY MEDICAL HISTORY. THE RESULT OF THE ANGIOGRAPHY EXAM WILL BE REQUESTED AGAIN. NO ADDITIONAL COMMENTS NOW. THE PATIENT WILL BE CONTACTED ONCE MORE ABOUT THE PATIENT'S PROGRESS AND RECOVERY. ON (B)(6) 2012 INFORMATION WAS RECEIVED THAT THE REPORTER HAS BEEN CONTACTED WITHOUT REPLY, SHE WILL BE CONTACTED AGAIN. ON (B)(6) 2012, THE PATIENT INFORMED THAT THE EVENT STILL PERSISTS AS 20/30 AND SHE CONTINUES USING EYE DROPS. ONCE MORE THE LSO REQUESTED THE RESULTS OF THE EXAM AND THE PATIENT INFORMED THAT SHE WILL PROVIDE IT BYE-MAIL. ON (B)(6) 2012 AND (B)(6) 2012, IT WAS DECIDED BY (B)(4) THAT SINCE THE PATIENT IS NOT YET FULLY RECOVERED AFTER 3 MONTHS AND A RELATION TO THE TREATMENT CANNOT BE TOTALLY EXCLUDED, THE CASE SHOULD BE REPORTED TO (B)(6) AS IT NOW IS ASSESSED AS FULFILLING THE SERIOUS CRITERIA 'PERMANENT IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE'. Q-MED IS AWARE THAT THIS QUESTION WAS INITIALLY RAISED AFTER 1 WEEK, HOWEVER, THAT WAS TOO SOON FOR ABOUT 3 MONTHS. ON (B)(6) 2012 AND (B)(6) 2012, THE CASE WAS REPORTED TO (B)(6) IN (B)(6). NINETY (90) DAYS FOLLOW UP QUESTIONS FROM (B)(6) WERE ALSO RECEIVED. ON (B)(6) 2013, THE PATIENT INFORMED THAT HER PROBLEM PERSIST, NEITHER IMPROVED NOR WORSENED. HER VISION IS 20/25 AND THE ALTERATION ON HER RIGHT EYE STILL PERSIST. SHE EXPLAINED THIS EVENT AS SCOTOMA [SCOTOMA]. ON (B)(6) 2013, SHE STOPPED USING HER EYEDROPS AND AROUND 30 DAYS AGO [END OF (B)(6) 2013] SHE WENT TO HER PHYSICIAN AGAIN. NEW EXAMS WERE PERFORMED BUT THE PATIENT DID NOT WANT TO PROVIDE FURTHER INFORMATION AT THIS MOMENT. THE PATIENT REQUESTED A NEW CONTACT ON (B)(6) 2013. ON (B)(6) 2013, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE EXAMS PERFORMED WERE SIMPLE RETINOGRAPHY AND VISUAL FIELDS. IF POSSIBLE SHE WILL SEND THE RESULTS BYE-MAIL. SHE DID NOT WANT (B)(4) TO FOLLOW UP FURTHER BECAUSE SHE BELIEVES IT WAS NO LONGER NECESSARY. THE OUTCOME FOR VISION LOST [VISUAL ACUITY REDUCED], ARTERY OCCLUSION [RETINAL ARTERY OCCLUSION] AND SCOTOMA [SCOTOMA] IS RECOVERING 1 RESOLVING. THE REPORTER'S CAUSALITY FOR THE CASE IS UNLIKELY. THE COMPANY'S CAUSALITY FOR THE CASE IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170748 PERLANE L, PERLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability