Description of Event or Problem · 0
THE PATIENT CAME TO OUR MEDSPA ASKING FOR ASSISTANCE POST DERMAL FILLER PLACEMENT FROM (B)(6) AT (B)(6) IN (B)(6). THE PATIENT WAS PROVIDED ONE LABEL FROM (B)(6) WHICH INCLUDED THE NAME OF THE PRODUCT (RHA 4) AND LOT NUMBER. PATIENT CAME TO OUR FACILITY WITH COMPLAINTS OF "FULLNESS" BENEATH LEFT ORBIT, REDNESS, FEVER, & A HARD LUMP. CLIENT WAS DIRECTED TO APPLY ICE AND TAKE BENADRYL PER (B)(6). PATIENT NOW HAS A LUMPY AND UNEVEN LEFT UNDEREYE WITH TINGLING EFFECT. THE CLIENT WAS TOLD BY (B)(6) THAT HER PRODUCT MAY HAVE BEEN A "BAD BATCH." WE ARE CONCERNED THAT IMPROPER USE OF DERMAL FILLER PRODUCTS, POSSIBLY NON-FDA REGULATED PRODUCTS, AND POOR TECHNIQUE MAY BE THE REASON FOR THE LARGE INFLUX OF CONCERNED CLIENTS IN OUR SURROUNDING AREA. MANY HAVE NEEDED AREAS CORRECTED OR EVEN DISSOLVED. FOR EXAMPLE, RHA 4 DERMAL FILLER HAS A HIGH G-PRIME OR VISCOSITY AND SHOULD NEVER BE PLACED INTO THE TEAR TROUGH AREA. THE CLIENT NOW HAS A DISFIGURED UNDEREYE. WITH THE RUMORS THAT THESE PRODUCTS MAY BE "FAKE" OR NON-FDA REGULATED, THE AESTHETICS COMMUNITY HESITATES TO ATTEMPT DISSOLVING OR CORRECTING THE AREAS AFFECTED BY (B)(6). PICS BELOW SHOW REDNESS AND EDEMA. THE CLOSE-UP PICTURE IS A WEEK LATER WHEN SWELLING SUBSIDED WHICH SHOWS THE TINGLING AFFECT. THE PICTURE OF THE LABEL SHOWS THE PRODUCT THAT WAS USED.