Description of Event or Problem · 1
IN (B)(6) 2012, OLYMPUS BIOTECH PVG RECEIVED A REPORT THAT A MALE PT, WHO RECEIVED OPGENRA ON (B)(4) 2012 AS PART OF AN UNIDENTIFIED SURGICAL PROCEDURE, DEVELOPED A 'RED WOUND' AND A TEMPERATURE APPROXIMATELY NINE DAYS FOLLOWING THE PROCEDURE. ON (B)(4) 2012, THE SURGEON REPORTED THAT HE DID NOT FEEL THAT THE EVENTS WERE RELATED TO THE USE OF THE OPGENRA. ON (B)(6) 2012, THE PHYSICIAN REPORTED THAT HE HAD NOT YET MADE THE DETERMINATION AS TO WHETHER THE REACTION WAS A 'DEEP INFECTION, CELLULITIS OR SIMPLY INFLAMMATION' BUT THAT ADDITIONAL INFO WOULD BE FORTHCOMING. ON (B)(6) 2012, THE PHYSICIAN CONFIRMED THAT THE PT RECEIVED TWO UNITS OF OPGENRA ON (B)(6) 2012 AS PART OF A PROCEDURE TO TREAT NON UNION OF L4-S1 AND LYTIC L5-S1 SPONDYLOLISTHESIS. DURING THE PROCEDURE A VITOSS FOAM PACK WAS ALSO IMPLANTED. APPROXIMATELY 13 DAYS POSTOPERATIVELY, THE PT EXPERIENCED 'SPREADING ERYTHEMA AND PYREXIA'. BLOOD CULTURES WERE NEGATIVE AND WOUND ASPIRATE WAS 'MICROBIOLOGY NEGATIVE.' AN MRI REVEALED THE PRESENCE OF A HEMATOMA WHICH WAS SUBSEQUENTLY ASPIRATED. THE PT RECEIVED BROAD SPECTRUM ANTIBIOTICS FOR CLINICAL DIAGNOSIS OF CELLULITIS. THE EVENTS, WHICH THE SURGEON DESCRIBED AS SERIOUS, REQUIRED REHOSPITALIZATION AND WERE REPORTED TO BE 'RESOLVING'. NO ADDITIONAL INFO IS EXPECTED.