PEAR PLATELET RICH PLASMA SYSTEM

Description of Event or Problem

I RECEIVED A PRP INJECTION IN BOTH KNEES AT (B)(6). THEY USED THE PEAK PLATELET RICH PLASMA SYSTEM (510K CLEARANCE ON MARCH 25, 2014: BK130053) TO PRODUCE A 3CC ALIQUOT OF PRP FROM 27CC OF MY BLOOD (PLUS 3CC OF ANTICOAGULANT) - SHE DID THIS TWICE, ONE FOR EACH KNEE. THE TECH PERFORMED THE AUTOMATED SEPARATION IN FRONT OF ME AND SHE APPEARED TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS FOR THIS AUTOMATED DEVICE. THE RESULTANT 3CC INJECTIONS WERE RED IN COLOR, NOT YELLOW; AND I SUBSEQUENTLY DID NOT NOTICE ANY BENEFIT FROM THESE INJECTIONS. I DON'T KNOW HOW THE 510K APPLICATION COULD CLAIM THIS DEVICE PRODUCES PLASMA (PLATELET-ENRICHED OR OTHERWISE) WHEN THE RESULTANT LIQUID IS RED INSTEAD OF YELLOW. ACCORDING TO THE PHYSICIAN, HE SPOKE TO THE REP BEFORE MY NEXT INJECTION, BUT THE REP COULD OFFER NO INSIGHT. CONSEQUENTLY, MY LAST PRP INJECTIONS WERE DONE USING OTHER TECHNOLOGY - WHICH RESULTED IN LIQUID THAT ACTUALLY LOOKED LIKE PLASMA, AND THE INJECTIONS SEEMED TO HAVE THE DESIRED EFFECT.