Description of Event or Problem · 1
ON 02/25/2012, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3 PERCENT LIDOCAINE). ON 02/28/2012, ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE. BASED UPON THE INFORMATION RECEIVED, THE CASE WAS UPGRADED TO SERIOUS, EXPECTED. MEDICAL HISTORY INCLUDED NO KNOWN ALLERGIES, IN GOOD HEALTH, AND NO CHRONIC CONDITIONS. THE PATIENT'S SKIN TYPE WAS REPORTED AS "AVERAGE COMPLEXION, AVERAGE TENDENCY TO BURN, FITZPATRICK III-IV." CONCOMITANT MEDICATIONS INCLUDED AN OVER-THE-COUNTER UNSPECIFIED MULTIVITAMIN DAILY AND NO PRESCRIPTION MEDICATIONS. THE PATIENT RECEIVED A 2 SYRINGE INJECTION (SYRINGE SIZE AND VOLUME UNK) OF RESTYLANE-L ON (B)(6) 2012 AT 2:00 PM TO THE NASOLABIAL LINES AND A SMALL AMOUNT TO THE FOREHEAD VIA AN UNKNOWN INJECTION TECHNIQUE OR INJECTION PATTERN. PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED NUMBING GEL APPLIED TO THE SKIN WHICH THE PATIENT THOUGHT MAY HAVE BEEN LIDOCAINE. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED AN INJECTION OF BOTOX (ONABOTULINUMTOXINA) TO THE FOREHEAD. ON (B)(6) 2012, IMMEDIATELY AFTER THE IMPLANTATION, THE PATIENT NOTICED BRUISING ON THE RIGHT SIDE OF THE NOSE, ALONG THE NASOLABIAL LINE. SEVERAL HOURS LATER THE PATIENT NOTED BLOTCHINESS ON BOTH SIDES OF THE NOSE AND ON THE CHEEKS, WHICH WAS DESCRIBED AS RED AND RASH-LIKE, AND LIGHTER AREAS THAN HER NORMAL SKIN TONE ON BOTH SIDES OF THE NOSE. THE BLOTCHINESS APPEARED TO BE SPREADING AND THE PATIENT WAS CONCERNED ABOUT A BLOOD VESSEL BEING BLOCKED. THE PATIENT SELF-TREATED WITH ICE PACKS, TOPICAL ARNICA AND VITAMIN K APPLIED TO THE SKIN. THE PATIENT HAD NOT BEEN SEEN BY A PHYSICIAN AND THE STAFF AT THE SPA WHERE THE PATIENT WAS INJECTED HAD NOT RETURNED THE PATIENT'S CALLS. AS OF (B)(6) 2012, THE BRUISING AND SKIN BLOTCHINESS WERE ONGOING. THE LOT NUMBER AND EXPIRATION DATE OF THE RESTYLANE-L WERE UNKNOWN. ON 02/28/2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE INJECTING NURSE. THE EVENT OF IMPLANT SITE PAIN WAS ADDED TO THE CASE. MEDICAL HISTORY INCLUDED NO KNOWN DRUG ALLERGIES (NKDA). THE PATIENT'S SKIN TYPE WAS REPORTED AS FITZPATRICK II. CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED A 2 ML INJECTION OF RESTYLANE-L (SYRINGE SIZE 1 ML) ON (B)(6) 2012 TO THE NASOLABIAL FOLD AND GLABELLAR LINES. PRE-PROCEDURE MEDICATIONS WERE REPORTED AS "NONE." ON (B)(6) 2012, DURING THE INJECTION, THE PATIENT EXPERIENCED SKIN BLANCHING, INTENSE PAIN, AND IMMEDIATE BRUISING. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) THAT NIGHT WITH SEVERE PAIN AND BLANCHING TO THE AREAS OF INJECTION. THE PATIENT WAS TREATED WITH DOXYCYCLINE AND A MEDROL DOSEPAK (METHYLPREDNISOLONE) AND DISCHARGED FROM THE ER. THE RESULT OF THE MEDICAL EVALUATION WAS "REACTION TO RESTYLANE-L." AS OF (B)(6) 2012, THE EVENTS PERSISTED AND THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2012 WITH A PHYSICIAN TO RECEIVE HYALURONIDASE TO REVERSE THE RESTYLANE-L. THE NURSE'S OPINION OF CAUSALITY WAS THAT THE EVENTS WERE RELATED TO THE TREATMENT. THE NURSE ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE 11286-2 AND JULY 2013, RESPECTIVELY. ON 03/02/2012, ADDITIONAL INFORMATION WAS RECEIVED FROM A PHYSICIAN. THE EVENTS OF HYPERSENSITIVITY, IMPLANT SITE NECROSIS, AND IMPLANT SITE SCAR WERE ADDED TO THE CASE. THE EVENT OF INJECTION SITE ERYTHEMA WAS SUBSUMED UNDER THE EVENT OF HYPERSENSITIVITY AND THE EVENT OF IMPLANT SITE RASH WAS SUBSUMED UNDER THE EVENT OF IMPLANT SITE ISCHAEMIA. MEDICAL HISTORY WAS REPORTED AS UNKNOWN. THE PATIENT'S SKIN TYPE WAS FITZPATRICK I-II. CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. THE PATIENT RECEIVED AN INJECTION (VOLUME NOT REPORTED) OF RESTYLANE-L FROM A 1 ML SYRINGE ON (B)(6) 2012 TO THE BILATERAL NASOLABIAL FOLDS AND A SMALL INJECTION TO THE GLABELLAR AREA. THE PATIENT DID NOT RECEIVE ANY PRE-PROCEDURE MEDICATIONS. ADDITIONAL PROCEDURES AT THE TIME OF IMPLANTATION INCLUDED "POSSIBLE" INJECTION OF BOTOX. ON (B)(6) 2012, AT THE TIME OF THE INJECTION, THE PATIENT HAD SIGNIFICANT BRUISING ON THE RIGHT SIDE (ALSO REPORTED AS A POSSIBLE HEMATOMA). LATER DURING THE DAY ON (B)(6) 2012, THE PATIENT DEVELOPED SIGNIFICANT SWELLING, BRUISING, AND REDNESS ON THE RIGHT CHEEK AND LEFT NASOLABIAL FOLD, WHICH CONTINUED TO THE RIGHT NOSE AREA; THE PHYSICIAN ATTRIBUTED THESE SYMPTOMS AS A HYPERSENSITIVITY REACTION.. THE PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT WITH THESE SYMPTOMS, ESPECIALLY ON THE RIGHT SIDE AND WAS SUBSEQUENTLY SEEN IN THE ER. THE PATIENT WAS TREATED WITH A MEDROL DOSEPAK AND DOXYCYCLINE ORALLY. ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PHYSICIAN ASSESSED THE AFFECTED AREA AND ALL AREAS WERE WELL PERFUSED; SUBSEQUENTLY, THE PHYSICIAN HAD SEEN THE PATIENT SEVERAL TIMES SINCE THE INJECTION AND THESE "REACTIONS" HAD IMPROVED. ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PATIENT DEVELOPED TWO SMALL LESIONS ON THE RIGHT CHEEK (REPORTED AS 3 MM BY 3 MM AND TOUCHING), WHICH THE PHYSICIAN ATTRIBUTED TO POSSIBLE TISSUE NECROSIS. THE PHYSICIAN ALSO STATED THAT THERE MIGHT BE A PROBLEM WITH SCARRING AT THE AREA OF THESE LESIONS. AS OF (B)(6) 2012, THE HYPERSENSITIVITY REACTION WAS BETTER. NO ADDITIONAL INFORMATION WAS PROVIDED. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE REPORTED AS UNKNOWN. THE PHYSICIAN'S OPINION OF CAUSALITY WAS THAT THE EVENTS WERE RELATED TO THE TREATMENT. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENTS AS "MODERATE TO SEVERE, DUE TO THE POSSIBILITY OF SCARRING". COMPANY COMMENT: THE EVENT OF HYPERSENSITIVITY HAS BEEN ASSESSED AS UNASSESSABLE AS NO TESTING OR LABORATORY STUDIES WERE PERFORMED.