EMBRACE SCAR THERAPY
Received Dec 27, 2021 · Event occurred Dec 1, 2018
Report MW5106286 · MDR key 13093312
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Neodyne Biosciences, Inc.Lot number
27720385
Product problems
- Product Quality Problem
Patient
44 YR · Female
- Pain
- Rash
- Ulcer
- Blister
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Pain
- Rash
- Ulcer
- Blister
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
I APPLIED THE EMBRACE SCAR STRIPS A COUPLE OF MONTHS AFTER MY SURGERY TO REDUCE SCARRING. THE ADHESIVE THAT KEEPS THE STRIP ADHERED TO THE BODY CAUSED ME TO HAVE SHARP AND BURNING PAIN. UPON REMOVAL I NOTICED BLISTERS, RED RASH AND SKIN ULCERS. THIS WAS ON LARGE AREAS OF SKIN AS THE STRIPS WERE USED IN MULTIPLE AREAS AT ONCE AND THEY WERE LARGE IN SIZE. I DISCONTINUED USAGE OF THE PRODUCT AND CONTACTED THE COMPANY. I EXPERIENCED SCARRING THAT FROM THE BLISTERS AND ULCERS, WHICH EVENTUALLY IMPROVED AFTER SEVERAL MONTHS. FDA SAFETY REPORT ID# (B)(4).