Description of Event or Problem · 1
INITIAL REPORT: THIS UNSOLICITED REPORT WAS RECEIVED FROM A CONSUMER VIA OUR AFFILIATE IN (B)(4) ON (B)(6) 2011. UPON MEDICAL REVIEW, THE EVENTS OF THIS CASE HAVE BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE ((B)(4)). A PTC (PRODUCT TECHNICAL COMPLAINT) HAS BEEN INITIATED FOR THIS REPORT: (B)(4). THIS REPORT INVOLVES A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH SCULPTRA (POLY-L-LACTIC ACID) IN (B)(6) 2008 AND (B)(6) 2009 (DOSAGE AND INDICATION NOT PROVIDED). MEDICAL HISTORY WAS NOT PROVIDED. NO CONCOMITANT MEDICATIONS WERE REPORTED. IN (B)(6) 2008 AND (B)(6) 2009, SHE RECEIVED ONE INJECTION TO THE RIGHT AND LEFT CHEEK/CHEEK BONE AREA. APPROXIMATELY 3-4 WEEKS AFTER THE INJECTION WITH POLY-L-LACTIC ACID IN (B)(6) 2009, THIS PATIENT DEVELOPED SWELLING AND SORENESS. IT WAS DESCRIBED AS BEING LIKE AN ABSCESS ON HER RIGHT AND LEFT SIDE OF HER FACE. THE SWELLING RECURRED EVERY 3-4 WEEKS. IT WOULD CLEAR AFTER THREE DAYS WITH OR WITHOUT ANTIBIOTICS. FOR THE FIRST TWO OCCASIONS THE PATIENT WAS ADMINISTERED ANTIBIOTICS NOS. SHE STATES THE EVENTS ARE NOW TAKING FIVE DAYS TO CLEAR AND RECUR EVERY 2-3 WEEKS. SHE HAS HAD "HYRIONIC ACID" TO TRY AND CORRECT THE EVENTS, BUT EXPERIENCED AN ALLERGIC REACTION. SHE IS DUE TO SEE A PLASTIC SURGEON ON (B)(6) 2011. OUTCOME: NOT RECOVERED. ACTION TAKEN: NOT APPLICABLE. REPORTER'S CAUSALITY ASSESSMENT: NOT APPLICABLE.