FDA Adverse Event Other Summary report: N

ARTEFILL

MDR report key: 1338195 · Received March 10, 2009

Report

Report Number
MW5010213
Event Type
Other
Date Received
March 10, 2009
Manufacturer
ARTES MEDICAL, INC.
Product Code
LMH
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAD A TERRIBLE UNEXPECTED AND IMMEDIATE REACTION TO ARTEFILL IN 2004. THE INVENTOR OF ARTEFILL. THEN. I HAD A FEW ACNE SCARS AND NASAL FOLDS "SMILE LINES". FOUR MONTHS LATER. - HOLE OPENED. POCK MARKS, DARK SPOTS FROM WHEN DR FIRST INJECTED IN 2002, DR CALLS THEM TATTOO MARKS CAUSED BY A JAGGED NEEDLE. EYEBROW PUFFY, GOOEY. SQUEEZED EYE BROW AND STUFF CAME OUT. I SAW ANOTHER DRS. DR(SECOND) TOOK PICTURES, PRESCRIBED CEPHALEXIN GENERIC FOR KEFLEX PULVULE 500 MG 4 X A DAY FOR 10 DAYS, RED AND WARM IN CHEEK. 2004 PM - LITTLE RED SHOT MARK ON INSIDE OF ARM COLLAGEN TEST FROM DR(SECOND) THE SAME DAY 2004 - PLASTIC BAG WITH CHUNKS I GOT OUT OF MY CHEEK. THE NEXT DAY AT 8 AM - HOLE IN CHEEK AND EYEBROW, RED NUMB IN CHEEK, ARM 2ND DAY. THE SAME DAY - MAKE-UP ON. I AM SHOWING HOLE (SNAPSHOT SAME DAY, CHEEK AND EYEBROW). SAME DAY AT PM - AFTER ALL DAY TAKING MEDS CEPHALEXIN 500MG. THE NEXT DAY - SQUEEZING, HURTING VERY PAINFUL, SHOWING LEFT SIDE OF CHEEK IS PUFFIER. SAW DR(SECOND) TO CHECK MY ARM FROM THE COLLAGEN TEST - FINE NO REACTION. THE SAME DAY AT PM - NUMB, HARD, PURPLE. THE SAME DAY AT II PM - TOP HOLE CLOSING. DR(SECOND) THINKS IT'S GETTING SOFTER. EYEBROW SWOLLEN AND HARD SQUEEZING HURTS STUFF COMES OUT. SAME DAY AT PM - MORE PUS THICK, WHITE CHUNK COMING OUT. SAME DAY AT PM - CHUNK CAME OUT OF EYEBROW ON FINGER. THE SAME DAY AT 11:30 PM - HOLE OPENED AFTER WASHING FACE. EYEBROW IS KILLING ME WITH PAIN. THE NEXT DAY AT AM - HOLE OPEN, PAIN IN EYEBROW OOZING. TWO DAYS PRIOR TO ORIGINAL DATE - HURTS, INDENT AREA BRUISED LOOKING, SECOND HOLE, PUFFIER LEFT CHEEK, EYE PUFFY, HOLE CLOSED AGAIN, TATTOO MARKS, OPENS AND CLOSES. A WEEK LATER - SCAB OFF EYEBROW, CHEEK, BOTTOM HOLE WHERE THE NEEDLE WENT IN IS NUMB I HAVE SOME FEELING CLEANING MAKE-UP OUT OF HOLE INDENT. PUFFIER LEFT. TWO DAYS LATER - EYE PUFFY, I CAN FEEL STUFF DEEP PAIN. I SAW DR(SECOND) AT 10 AM. ASKED IF I NEEDED AN MRI BECAUSE OF THE DEEP PAIN IN THE CHEEK AND EYEBROW, HE SAID NO. CHEEK, INDENT, LINE, HOLE, LITTLE SOFTER. SAME DAY AT 8:20 PM - SAW DR(SECOND). FIRST DR WROTE ME AN EMAIL SAID, I HAD A REACTION TO COLLAGEN. IT'S MY FAULT. FACE AND EYE HURTS. THE SAME DAY - GUSHING OOZING OUT PAINFUL DISTURBING TO SEE I CRY, HURTS (DEEP PAIN IN CHEEK). SAME DAY - SQUEEZING ON CAMERA, WHITE STUFF COMING OUT, FREAKING OUT I AM CRYING, MORE THAN BLOOD, VERY PAINFUL, BLOOD CLOT, SHOWING SUBSTANCE ON FINGER GOOEY THICKER WORMLIKE. THE NEXT DAY AT 8:30 PM - BAND-AID. THE FOLLOWING DAY AT 7 AM - DARK TATTOO MARKS POCK MARKS EYE HURTS SORE SOME FEELING. THE FOLLOWING MONTH - HURTING PAINFUL. THE SAME DAY - LIGHT PURPLE HARD IN MIDDLE LUMP ON BIG TOP HOLE. THE FOLLOWING MONTH AT 7:30 AM - CHEEK, CLOSED HOLE, THROBBING IN MIDDLE BETTER, HOLES IN CHEEK, EYEBROW. BIGGER HOLE HURTING. THE SAME DAY - MY FACE WAS THROBBING THIS MORNING SO, I CALLED DR(SECOND), HE PRESCRIBED MORE CEPHALEXIN 500MG 4 X A DAY. TWO DAYS LATER - TAKING MEDS. TATTOO POCK MARKS. CALLS THEM TATTOO MARKS FROM THE NEEDLE BEING JAGGED. DARK RED AND PURPLE CHEEK. EYEBROW FILL HOLE WITH MAKE UP. A WEEK LATER AT 11;30 PM - SNAPSHOT UGLY. I SAW DR(SECOND). TWO DAYS LATER - I AM OFF ANTIBIOTICS FOR A FEW DAYS. HURTING ACHY THROBBING PAIN IN CHEEK EYE PUFFY HURTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ARTEFILL NONE LMH ARTES MEDICAL, INC.

Patients

Seq Age Sex Outcome Treatment
1