BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTAYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3963951 · Received July 14, 2014

    Report

    Report Number
    2032896-2014-00610
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    January 21, 2014
    Report Date
    June 13, 2014
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECOND DEVICE: PERLNEL, PERLANE INJECTABLE DERMAL FILLER; LOT #12624; IMPLANT DATE: (B)(6), 2014. THIRD DEVICE: EMERVEL TOUCH, OTHER THERAPEUTIC PRODUCTS; LOT #S212136006. THE MANUFACTURER'S DEVICE ANALYSIS RESULTS: A TREND ANALYSIS SHOWS THAT THERE IS NO INCREASED TREND OF MEDICAL COMPLAINTS REPORTED FOR RESTYLANE LIDOCAINE (LOT NUMBER 12624), RESTYLANE PERLANE LIDOCAINE (LOT NUMBER 12398) OR EMERVEL TOUCH (LOT NUMBER 82121360006). A BATCH RECORD REVIEW OF RESTYLANE LIDOCAINE (LOT NUMBER 12624), RESTYLANE PERLANE LIDOCAINE (LOT NUMBER 12398) AND EMERVEL TOUCH (LOT NUMBER 82121360006) DID NOT REVEAL ANY DEVIATIONS OR OTHER OBSERVATIONS THAT INDICATE ANY PRODUCT DEFICIENCIES. ALL CHEMICAL AND MICROBIOLOGICAL TEST RESULTS WERE WITHIN THE SPECIFICATION LIMITS. MANUFACTURER COMMENTS: A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT IS POSSIBLE. HOWEVER, PREVIOUS FILLER TREATMENTS MIGHT BE A CONTRIBUTING FACTOR. THE EVENTS ARE ADDRESSED IN THE LABELING FOR THE RESTYLANE PRODUCTS AND AN INSTRUCTION FOR USE UPDATE IS ON-GOING FOR EMERVEL TOUCH. THIS CASE IS LINKED TO (B)(4). FOR REFERENCE PURPOSE ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4). THIS CASE WAS RECEIVED BY (B)(4) ON (B)(4) 2014 AND WAS FORWARDED TO (B)(4) ON (B)(4) 2014. PHARMACOVIGILANCE COMMENT: (B)(6) 2014: THE EVENTS IMPLANT SITE EXTRAVASATION, IMPLANT SITE SCAR, IMPLANT SITE SWELLING ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS IS A VERBATIM REPORT AS RECEIVED BY (B)(4). (B)(4) ARE SPONTANEOUS CASE REPORTS SENT BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED (B)(6). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPOTHYROIDISM [HYPOTHYROIDISM] FOR WHICH SHE IS TAKING THYROXINE. THE PATIENT HAS NO HISTORY OF ALLERGIES. THE PATIENT HAS A HISTORY OF PREVIOUS FILLER TREATMENTS {TESOYLA, SCULPTRA, RESTYLANE, RESTYLANE PERLANE} BETWEEN 2002-2013. ON (B)(6) 2013 THE PATIENT WAS INJECTED WITH EMERVEL TOUCH (LOT NUMBER 52121360006) TO THE DERMIS OF CHEEKS, 0.3 M1 LEFT SIDE AND 0.7 M1 RIGHT SIDE WITH NEEDLE, RESTYLANE PERLANE LIDOCAINE {LOT NUMBER 12398) SUBDERMAL TO CHEEKS, 1 M1 EACH SIDE WITH CANNULA, AND AZZALURE TO CROWS FEET AND GLABELLAR AREAS. WITHIN 24 HOURS OF TREATMENT THE PATIENT HAD ONSET OF RIGHT-SIDED SWELLING [IMPLANT SITE SWELLING] OF UPPER AND LOWER EYELID. THE SWELLING WAS SEVERE WITHIN 48 HOURS. THE PATIENT ALSO EXPERIENCED SEVERE RIGHT-SIDED ERYTHEMA [IMPLANT SITE ERYTHEMA], SEVERE RIGHT-SIDED TENDERNESS [IMPLANT SITE PAIN] AND PALPABLE FIRM MASS [IMPLANT SITE INDURATION] OF 3X5 EM OF RIGHT ZYGOMA. ON (B)(6) 2014 THE PATIENT WAS INJECTED WITH 1 ML RESTYLANE LIDOCAINE (LOT NUMBER 12624, SUBDERMAL PLACEMENT USING A 27G CANNULA) IN THE LEFT CHEEK. ON (B)(6) 2014, THIRTEEN DAYS POST-INJECTION, THE PATIENT HAD ONSET OF SWELLING [ SWELLING] IN THE LEFT CHEEK. THE REPORTING PHYSICIAN DESCRIBES THE EVENT AS "JELLY-LIKE SUBSTANCE ERUPTING THROUGH SKIN [IMPLANT SITE EFFUSION] AND ASSESSED THE SEVERITY AS MODERATE. THE PATIENT ALSO HAD SWELLING AND ERUPTION OF JELLY-LIKE SUBSTANCE (HA FILLER) OF THE RIGHT CHEEK WHERE RESTYLANE WAS INJECTED IN (B)(6) 2013. THE PATIENT WAS TREATED WITH HYLASE INJECTIONS TO DISSOLVE THE RESTYLANE ON BOTH SIDES OF HER FACE. THE REPORTER ALSO EXTRACTED SOME JELLY-LIKE SUBSTANCE FROM THE SWOLLEN AREA IN HER RIGHT CHEEK. THE PATIENT HAS NOT HAD ANY FURTHER ERUPTIONS, BUT HAS LOST FACIAL VOLUME {WORSE ON THE LEFT SIDE) THE REPORTING PHYSICIAN HAS ASSESSED THE CASE AS SERIOUS DUE TO SCARRING [IMPLANT SITE SCAR] IN AREAS WHERE SKIN ERUPTED AND LOSS OF VOLUME IN THE LEFT CHEEK FOLLOWING TREATMENT WITH HYALASE. THE REPORTER ASSESSED THE OUTCOME FOR THE EVENTS STARTING IN (B)(6) 2013: SWELLING [IMPLANT SITE SWELLING], ERYTHEMA [IMPLANT SITE ERYTHEMA], FIRM MASS [IMPLANT SITE INDURATION] AND TENDERNESS [IMPLANT SITE PAIN] AS RECOVERED I RESOLVED. THE OUTCOME FOR THE EVENTS STARTING IN (B)(6) 2014: SWELLING [IMPLANT SITE SWELLING] AND "JELLY-LIKE SUBSTANCE ERUPTING THROUGH SKIN" [IMPLANT SITE EFFUSION] IS RECOVERED I RESOLVED WITH SEQUELAE (SCARRING [IMPLANT SITE SCAR]). AS CORRECTIVE TREATMENT FOR THE EVENTS STARTING IN (B)(6) 2013 THE PATIENT RECEIVED THE FOLLOWING TREATMENTS: FLUCLOXACILLIN 500 MG FOUR TIMES A DAY, DOXYCYCLINE 100 MG ONCE DAILY FOR ONE WEEK, PREDNISOLONE 30 MG DAILY FOR 5-7 DAYS THEN REDUCING DOSE AND CETRIZINE 10 MG ONCE DAILY UNTIL (B)(6) 2014. THE EVENTS INITIALLY IMPROVED BUT THE SWELLING INCREASED AGAIN AFTER A FEW DAYS SO PREDNISOLONE WAS INCREASED TO 30 MG AGAIN. AS CORRECTIVE TREATMENT FOR THE EVENTS STARTING IN (B)(6) 2014 THE PATIENT RECEIVED PREDNISOLONE 30 MG OD, DOXYCYCLINE 100 MG 00, AND ANTIHISTAMINES. THE PATIENT WAS ALSO TREATED WITH HYLASE INJECTIONS TO DISSOLVE THE RESTYLANE ON BOTH SIDES OF HER FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409293 RESTAYLANE L, RESTYLANE LIDOCAINE INJECTABLE DERMAL FILLER LMH 12624

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other RIGHT-SIDED SWELLING/SWELLING IN THE LEFT CHEEK,| (IMPLANT SITE SWELLING (B)(4)| JELLY-LIKE SUBSTANCE ERUPTING THROUGH SKIN,| (IMPLANT SITE SCAR (B)(4)| SCARRING IN AREAS WHERE SKIN ERUPTED ,| (IMPLANT SITE EXTRAVASATION (B)(4)