Description of Event or Problem · 1
ON 06/25/2012, A SPONTANEOUS REPORT BY A REGISTERED NURSE (RN) WAS RECEIVED FROM A COMPANY REPRESENTATIVE VIA FAX REGARDING A PT (AGE AND SEX NOT REPORTED) WHO RECEIVED AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). ON 06/27/2012, ADDITIONAL INFO WAS RECEIVED FROM THE RN. THE PRODUCT WAS CONFIRMED AS PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE), NOT PERLANE AS WAS PREVIOUSLY REPORTED. BASED ON THE ADDITIONAL INFO RECEIVED ON 06/27/2012, THE CASE WAS UPGRADED TO UNEXPECTED SEVERITY. MEDICAL HISTORY, PT SKIN TYPE, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED AN INJECTION (VOLUME INJECTED AND SYRINGE SIZE NOT REPORTED) OF PERLANE ON AN UNK DATE TO AN UNSPECIFIED SITE. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF THE IMPLANTATION WERE NOT REPORTED. ON AN UNK DATE, THE PT EXPERIENCED AN ADVERSE REACTION. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED. ON 06/27/2012, ADDITIONAL INFO WAS RECEIVED FROM THE RN. THE EVENT OF ADVERSE EVENT WAS REPLACED WITH THE EVENTS OF ACNE CYSTIC AND FURUNCLE. THE RN REPORTED THE PT TO BE A (B)(6) FEMALE. MEDICAL HISTORY INCLUDED CHRONIC HIVES AS A CHILD, ANXIETY, AND PREVIOUS INJECTION OF PERLANE-L TO THE CHIN AREA WITHOUT PROBLEMS (ON AN UNSPECIFIED DATE IN (B)(6) 2012). THE PT'S SKIN TYPE WAS FITZPATRICK III. CONCOMITANT MEDICATIONS INCLUDED VALIUM (DIAZEPAM) AND PRILOSEC (OMEPRAZOLE). THE PT RECEIVED A 2 ML TOTAL INJECTION OF PERLANE-L FROM 1 ML SYRINGES ON (B)(6) 2012 TO THE CHIN VIA LINEAR THREADING TECHNIQUE. PRE-PROCEDURE MEDICATIONS INCLUDED BLT 20/6/4 (BENZOCAINE 20%, LIDOCAINE 6%, AND TETRACAINE 4%). NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF THE IMPLANTATION. ON AN UNSPECIFIED DATE IN (B)(6) 2012, AFTER THE IMPLANTATION, THE PT EXPERIENCED BIG CYSTIC-TYPE ACNE. ON (B)(6) 2012, THE PT PRESENTED TO THE CLINIC WITH BIG CYSTIC-TYPE ACNE AND REDNESS TO THE AREA POST INJECTION. THE PT WAS STARTED ON AMOXICILLIN AND WENT TO (B)(6). ON UNSPECIFIED DATES IN 2012, THE PT REPORTED THAT SHE SAW MULTIPLE HEALTHCARE PROVIDERS IN (B)(6) FOR HER COMPLAINTS OF THE BIG CYSTIC-TYPE ACNE THAT TURNED INTO HUMONGOUS BOILS. THE PT REPORTED THAT THE BOILS WERE INCISED AND DRAINED AND THAT ALL CULTURES WERE NEGATIVE. THE HEALTHCARE PROVIDERS IN (B)(6) ENCOURAGED WARM PACKS AND GAVE UNSPECIFIED ANTIBIOTICS. THE PT REPORTED THAT SOME OF THE BOILS WERE SURGICALLY REMOVED AND HER HUSBAND STATED THAT THEY PULLED SOMETHING OUT OF THE AREA THAT "LOOKED LIKE A TOOTHPICK." AS OF AN UNSPECIFIED DATE IN THE LAST WEEK OF (B)(6) 2012, THERE WAS MILD REDNESS IN THE AREA AND ALL THE BOILS HAD RESOLVED. THE RN'S OPINION OF CAUSALITY WAS THAT THE TREATMENT CAUSED THE REPORTED EVENTS. THE RN ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE WERE 11240 AND 06/2013, RESPECTIVELY.