Description of Event or Problem · 1
INITIAL REPORT: THIS NON-SERIOUS UNSOLICITED REPORT WAS RECEIVED FROM A PHYSICIAN TO A COMPANY MARKETING AND SALES COORDINATOR VIA OUR AFFILIATE IN (B)(4) ON (B)(6) 2011. (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE, WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) (DOSAGES, INDICATION AND THERAPY DATES NOT INDICATED) SEVERAL TIMES (NOS) APPROXIMATELY EVERY SIX MONTHS. ON AN UNK DATE SHE EXPERIENCED WHEALS IN THE DEEPER TISSUES BOTH AT THE CHEEK AREA AND AT THE JAW AREA ALONG WITH PAPULES ON THE SURFACE OF THE SKIN AT THE CHEEK AREA. CORRECTIVE TREATMENT AND ACTION TAKEN WITH POLY-L-LACTIC ACID IS UNK. THE PT HAS NOT RECOVERED AT THE TIME OF THIS REPORT. OTHER SUSPECT DRUGS - NONE. SIGNIFICANT/RELEVANT MEDICAL HISTORY - NOT REPORTED. RELEVANT CONCOMITANT MEDICATIONS - UNK. ACTION TAKEN: UNK. CORRECTIVE TREATMENT - UNK. OUTCOME - NOT RECOVERED/NOT RESOLVED. PHYSICIAN/RPTR CAUSALITY: NOT INDICATED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011: RESULTS FOR (B)(4) WERE RECEIVED AND INDICATED THE FOLLOWING INFO: SINCE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MFG BATCHES MARKETED IN (B)(6) AND THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT ISN'T BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011: UPON MEDICAL REVIEW, THE EVENT OF THIS CASE HAVE BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENTS FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE ((B)(4)). FOLLOW-UP INFO INDICATES THE PT WAS TREATED WITH POLY-L-LACTIC ACID RECONSTITUTED WITH A 8 ML OF STERILE WATER AND 2 ML OF LIDOCAINE 2% ON (B)(6) 2009, (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010. ON (B)(6) 2009, POLY-L-LACTIC WAS RECONSTITUTED WITH STERILE WATER 8 ML + 8 ML AND LIDOCAINE 2 ML + 2 ML. THE TOTAL VOLUME OF POLY-L-LACTIC ADMINISTERED WAS 0.7 ML X 2 TO THE NASOLABIAL FOLDS, MARIONETTE LINES, TEMPLES, CHEEK LINES AND LABIOMENTAL CREASE USING CROSS HATCH, DEPOT AND DEEP DERMAL INJECTION TECHNIQUE. MESSAGE WAS PERFORMED DURING THE TREATMENT AND THEN BY THE PT. IN FOLLOW UP INFO REQUESTING A DESCRIPTION OF ALL ADVERSE EVENTS EXPERIENCED, THE WHEALS WERE NOT MENTIONED. THE EVENT WAS DESCRIBED AS INFECTED PAPULES IN CHEEKS, PAIN, AND INVISIBLE NODULES CHIN. IN (B)(6) 2010, THIS PT EXPERIENCED SIX INVISIBLE NODULES ON THE CHIN THAT WERE <5 MM. IN (B)(6) 2011, INFECTED PAPULES IN THE CHEEKS WERE PAIN DEVELOPED WITH SIGNS OF INFLAMMATION (SWELLING). THERE WAS NO EVIDENCE OF A SYSTEMIC PROCESS. THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND ORAL CORTICOSTEROIDS (DOSAGES NOT PROVIDED). THE PT RECOVERED FROM THE INFECTION, BUT THE NON-VISIBLE PAPULES PERSISTED. NO SURGICAL INTERVENTION WAS ADMINISTERED. THERE WAS NO EVIDENCE OF PERMANENT IMPAIRMENT OF BODY FUNCTION OR STRUCTURE. THE EVENT OF INFECTION RESOLVED ON (B)(6) 2011. PT HISTORY INCLUDES FITZPATRICK SKIN TYPE II, NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN-VASCULAR DISEASE, WEIGHT LOSS (B)(6) AND EX-SMOKER.