Description of Event or Problem · 1
ON (B)(4) 2011, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REP REGARDING A (B)(6) MALE WHO RECEIVED AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). ON (B)(4) 2011, ADD'L INFO WAS RECEIVED FROM THE PHYSICIAN. BASED UPON THE INFO RECEIVED, THE CASE WAS UPGRADED TO SERIOUS FOR UNEXPECTED SEVERITY. MEDICAL HISTORY WAS NOT REPORTED, AS THE PHYSICIAN DID NOT HAVE THE CHART AVAILABLE. THE PT'S SKIN TYPE WAS FITZPATRICK IV. THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT RECEIVED A 0.25 ML INJECTION FROM A 1 ML SYRINGE OF RESTYLANE-L ON (B)(6) 2011 TO THE FOREHEAD AND LEFT BROW (0.25 ML WAS SPREAD OUT BETWEEN THE SITES OVER 4 INJECTIONS; 0.1 ML ALIQUOT) USING A "DEEP TO SUBDERMAL" INJECTION TECHNIQUE. NO PRE-PROCEDURE MEDICATION WAS USED. ADD'L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED A 12 UNIT INJECTION OF BOTOX (ONABOTULINUMTOXINA) TO THE FOREHEAD. ON (B)(6) 2011, AFTER THE IMPLANTATION, THE PT DEVELOPED BRUISING AND BLOTCHINESS FROM THE NASAL BRIDGE TO THE HAIRLINE ON THE CONTRALATERAL SIDE AT THE INJECTION SITE. ON (B)(6) 2011, THE PT CALLED THE INJECTING PHYSICIAN TO REPORT THE EVENTS. AT THE TIME, THE INJECTING PHYSICIAN PRESUMED THAT HE HAD HIT THE SUPRATROCHLEAR ARTERY AND THE PT WAS TO BE EVALUATED THAT DAY. ON (B)(6) 2011, THE PT WAS EVALUATED BY THE INJECTING PHYSICIAN AND HAD SOME NECROTIC TISSUE ON THE GLABELLA AND FOREHEAD AND THE SKIN WAS BLACKISH. ON EITHER (B)(6) 2011 OR (B)(6) 2011, THE PT RECEIVED A 75 UNIT INJECTION OF HYALURONIDASE. ADD'L TREATMENTS INCLUDED WARM COMPRESSES, MASSAGE, NITROPASTE (NITROGLYCERIN) AND ASPIRIN (ACETYLSALICYLIC ACID). ON (B)(6) 2011, THE INJECTING PHYSICIAN STATED, "THAT IT DIDN'T MAKE SENSE THAT HE HAD HIT THE SUPRATROCHLEAR ARTERY AS THE AREA AFFECTED WAS CONTRALATERAL AND THE SUPRATROCHLEAR ARTERY RUNS IN THE PATTERN OF MOST MEDIAL INJECTION." THE PHYSICIAN PLANNED TO SEE THE PT ON (B)(6) 2011 AND STATED THAT AFTER EVALUATING THE PT HE WOULD HAVE A BETTER IDEA OF THE SITUATION. ON (B)(6) 2011, THE INJECTING PHYSICIAN'S ADMINISTRATIVE ASSISTANT CONFIRMED THAT THE PT WAS EVALUATED ON (B)(6) 2011 AND SHE BELIEVED THE PT'S EVENTS WERE WORSE THAN THEY WERE AT THE PT'S PREVIOUS EVAL. THE ADMINISTRATIVE ASSISTANT DID NOT HAVE ANY FURTHER DETAILS TO PROVIDE, AS SHE COULD NOT LOCATE THE PT'S CHART. THE INJECTING PHYSICIAN STATED THAT THE TREATMENT WITH RESTYLANE-L CAUSED THE REPORTED EVENTS. THE INJECTING PHYSICIAN ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS SEVERE. THE LOT NUMBER AND EXP DATE WERE 10717 AND FEB-2012, RESPECTIVELY.