EMBRACE SCAR THERAPY
Received Nov 1, 2019 · Event occurred Oct 29, 2019
Report MW5090842 · MDR key 9271670
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Neodyne Biosciences, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
24 YR
- Hypersensitivity/Allergic reaction
- Rash
- Burning Sensation
- No Code Available
- Hypersensitivity/Allergic reaction
- Rash
- Burning Sensation
- No Code Available
Narrative
Description of Event or Problem
I HAD A BREAST REDUCTION / LIFT SURGERY 13 WEEKS AGO. I WAS HAPPY WITH MY RESULTS, BUT WANTED TO DO EVERYTHING I COULD IN ORDER TO PREVENT SCARRING. I RESEARCHED ABOUT EMBRACE SCAR THERAPY AND LIKED THAT IT WAS FDA APPROVED AND SHOWED POSITIVE RESULTS IN CLINICAL TRIALS. I ASKED MY PLASTIC SURGEON WHAT HE THOUGHT, AND HE RECOMMENDED I USE THE PRODUCT. AFTER MY FIRST APPLICATION (60 DAYS ARE RECOMMENDED) I NOTICED BLISTERING, BURNING, RASHES, AND EVEN CHUNKS OF MY SKIN THAT HAD PEELED OFF ONTO THE SILICONE STRIPS. MY BREASTS LOOK TOTALLY DISFIGURED NOW, AND THEY WERE AMAZING BEFORE I USED THIS PRODUCT. IT EVEN HAS 2.8 OUT OF 5 STAR RATING ON (B)(6). CAN'T BELIEVE THIS IS FDA APPROVED, IT COMPLETELY RUINED MY (B)(6) SURGERY AND MY SELF ESTEEM. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? DOESN'T APPLY. DATES OF USE: (B)(6) 2019. PRODUCT TYPE: OVER-THE-COUNTER.