Description of Event or Problem · 1
ON (B)(4) 2012, A SPONTANEOUS REPORT WAS RECEIVED FROM A REGISTERED NURSE (RN) REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF PERLAN-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE RN. BASED ON THE INFORMATION RECEIVED THE CASE WAS UPGRADED DUE TO UNEXPECTED SEVERITY. MEDICAL HISTORY INCLUDED NO MEDICAL CONDITIONS OR ALLERGIES THAT THE RN WAS AWARE OF; A PREVIOUS INJECTION OF JUVEDERM (CROSS-LIKELY HYALURONIC ACID DERMAL FILLER) ON AN UNSPECIFIED DATE IN (B)(6) 2011 TO AN UNSPECIFIED SITE, WITH NO COMPLICATIONS; AND A PREVIOUS INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) ON AN UNSPECIFIED DATE IN (B)(6) 2011 TO AN UNSPECIFIED SITE, WITH NO COMPLICATIONS. THE PATIENT'S SKIN TYPE WAS REPORTED AS "(B)(6)". CONCOMITANT MEDICATIONS WERE UNKNOWN, AS "THE PATIENT DID NOT LIST ANY". THE PATIENT RECEIVED AN INJECTION OF PERLANE-L FROM A 1 ML SYRINGE ON (B)(6) 2012 TO THE CHEEKS, UPPER NASOLABIAL FOLDS, GLABELLAR LINES, AND MID CHIN AREA (APPROXIMATELY 0.1 ML IMPLANTED PER SITE) VIA THREADING INJECTION TECHNIQUE. THE PATIENT DID NOT RECEIVE ANY PRE-PROCEDURE MEDICATIONS. COLD AIR WAS ADMINISTERED PRIOR TO THE TREATMENT. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN (B)(6) 2012, AFTER THE IMPLANTATION, THE PATIENT DEVELOPED LUMPS ON BOTH SIDES OF HER NOSE. ON (B)(6) 2012, THE PATIENT CALLED THE RN TO REPORT THE LUMPS ON BOTH SIDES OF HER NOSE. THE RN ADVISED THE PATIENT TO COME IN TO THE CLINIC ON (B)(6) 2012, TO HAVE THE AREA MASSAGED. ON JUNE 08, 2012, AFTER HER CALL TO THE RN, THE PATIENT MASSAGED THE AREA HERSELF. ON (B)(6) 2012, THE PATIENT WOKE UP WITH SWELLING IN HER CHEEKS AND UPPER NASOLABIAL LINES; THE SWELLING WAS WORSE ON THE LEFT SIDE OF HER FACE AND HER LEFT EYE WAS ALMOST SWOLLEN SHUT. ON (B)(6) 2012, THE SWELLING "CHANGED OR SHIFTED POSITION" AND WENT DOWN SOME. ON (B)(6) 2012, THE PATIENT'S SWELLING CONTINUED TO DECREASE. ON (B)(6) 2012, THERE WAS NO CHANGE. ON (B)(6) 2012, THE PATIENT WAS EVALUATED BY THE RN. THE RN NOTED THE PATIENT HAD MODERATE SWELLING IN HER LEFT CHEEK AND UPPER NASOLABIAL LINES, WITH FIRM TISSUE. THE PATIENT WAS AFRAID TO HAVE THE RN MASSAGE THE SITE AND REQUESTED A STEROID SHOT. THE RN OPTED TO PRESCRIBE A METHYLPREDNISOLONE DOSE PACK, RATHER THAN ADMINISTER AN INJECTION. ON (B)(6) 2012, THE PATIENT WAS EVALUATED BY THE RN AND CLINIC PHYSICIAN. AT THIS VISIT, THE PATIENT REPORTED THAT THE SWELLING HAD RESOLVED, BUT HAD RETURNED ON AN UNSPECIFIED DATE IN (B)(6) 2012, AFTER STOPPING TREATMENT WITH THE METHYLPREDNISOLONE DOSE PACK. THE PATIENT WAS NOTED TO HAVE SWELLING IN THE CHEEKS WITH FIRM TISSUE, BUT IT WAS NOT AS HARD AS IT HAD BEEN AT THE PREVIOUS VISIT. THE CLINIC PHYSICIAN RECOMMENDED THAT THE PATIENT TAKE AN ANTIHISTAMINE AND IBUPROFEN OR ALEVE (NAPROXEN) DAILY. THE RN ENCOURAGED THE PATIENT TO WAIT ANOTHER WEEK BEFORE DOING ANYTHING ELSE. ON (B)(6) 2012, THE PATIENT WAS EVALUATED BY THE RN. THE SWELLING WAS STILL PRESENT WITH FIRM TISSUE; THE SWELLING TO THE LEFT SIDE OF THE PATIENT'S CHEEK AND NASOLABIAL FOLDS WAS WORSE THAN THE RIGHT, BUT HAD IMPROVED. THE RN INJECTED VITRASE (HYALURONIDASE) INTO THE HARDER AREAS IN THE CHEEK, NASOLABIAL FOLDS, AND GLABELLAR LINES. AS OF (B)(6) 2012, THE PATIENT REPORTED THAT HER CHEEK AREAS WERE SOFTER, BUT THE GLABELLAR LINES HAD NOT CHANGED. NO TESTS OR LABORATORY STUDIES HAD BEEN PERFORMED. THE PATIENT WAS SCHEDULED TO BE EVALUATED THE EVENING OF (B)(6) 2012. THE RN'S OPINION OF CAUSALITY WAS THAT THE PERLANE-L TREATMENT CAUSED THE REPORTED EVENTS. THE RN ASSESSED THE SEVERITY OF THE EVENTS AS "MILD, THOUGH THE PATIENT FELT IT WAS SEVERE." THE LOT NUMBER AND EXPIRATION DATE FOR PERLANE-LA WERE 11240 AND JUNE 2013, RESPECTIVELY. ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE RN. ON (B)(6) 2012, THE PATIENT WAS PRESCRIBED CIPRO (CIPROFLOXACIN) 500 MG FOR 2 WEEKS. AS OF (B)(6) 2012, THE LUMPS ON BOTH SIDE OF THE PATIENT'S NOSE WERE ONGOING. THE SWELLING IN THE CHEEKS AND UPPER NASOLABIAL LINES WITH FIRM TISSUE AND FIRM TISSUE ALONG THE GLABELLAR LINES WAS ONGOING AND IMPROVED. A CONFIRMATIVE DIAGNOSIS HAD NOT BEEN ESTABLISHED. FURTHER FOLLOW-UP WITH THE PATIENT WAS PLANNED; THE PATIENT WAS TO CALL THE REPORTING CLINIC AT HER CONVENIENCE. ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE RN. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR LATER ON (B)(6) 2012. ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE RN. BASED ON THE INFORMATION RECEIVED, THE EVENT OF IMPLANT SITE ABSCESS WAS ADDED. ON (B)(6) 2012, THE PATIENT WAS EVALUATED. AT THIS VISIT, IT WAS NOTED THAT THE LUMP ON THE LET SIDE OF THE PATIENT'S NOSE AND SWELLING WITH FIRM TISSUE IN BOTH CHEEKS AND UPPER NASOLABIAL LINES, HAD IMPROVED, BUT THE LUMPS AND SWELLING ON THE RIGHT SIDE WERE WORSE THAN BEFORE. THE FIRM AREA ALONG THE GLABELLAR LINES ON THE PATIENT'S FOREHEAD HAD FORMED (ALSO REPORTED AS "TURNED INTO") AN ABSCESS (ALSO REPORTED AS "SOME SORT OF ABSCESS"), WHICH WAS DRAINED AND CULTURED. TREATMENT WITH CIPRO AT 500 MG ORALLY TWICE DAILY WAS REFILLED FOR 2 MORE WEEKS, FOR A TOTAL OF 4 WEEKS OF TREATMENT. AS OF (B)(6) 2012, THE CULTURE RESULTS REVEALED NO ORGANISM OR WHITE BLOOD CELLS. THE RN AGREED TO PROVIDE RESULTS OF THE GRAM STAIN OF THE CULTURE AT A LATER DATE. THE PATIENT WAS SCHEDULED FOR AN EVALUATION ON (B)(6) 2012, AND POSSIBLE TREATMENT WITH AN ADDITIONAL INJECTION OF HYALURONIDASE TO THE RIGHT SIDE WOULD BE CONSIDERED, DEPENDANT ON THE PATIENT'S STATUS. ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINIC RECEPTIONIST. THE PATIENT WAS NOT SEEN N (B)(6) 2012, AS PREVIOUSLY SCHEDULED. THE PATIENT RESCHEDULED HER APPOINTMENT TO (B)(6) 2012.