InjuryMDA
SCARAWAY SILICONE SHEETS
Received Jan 2, 2025 · Event occurred Dec 20, 2024
Report MW5164100 · MDR key 21054484
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Alliance Pharma Inc.Catalog number
358962203305
Patient
45 YR · Female
- Hypersensitivity/Allergic reaction
- Rash
- Fluid Discharge
- Blister
- Hypersensitivity/Allergic reaction
- Rash
- Fluid Discharge
- Blister
Narrative
Description of Event or Problem
I APPLIED THIS DRESSING TO MY INCISION 5 WEEKS POST-OP. I APPLIED IT AFTER MY SHOWER BEFORE GOING TO BED AND AWOKE TO A HORRIBLE REACTION. I HAVE A RASH COMBINED WITH BLISTERED SKIN, MY CLOSED INCISION IS NOW SEEPING FLUIDS. I HAVE A KNOWN ADHESIVE ALLERGY TO CERTAIN TYPES OF ACRYLIC BASED ADHESIVES, I DO NOT HAVE AN ALLERGY TO SILICONE. THESE ARE LABELED AS 100% MEDICAL GRADE SILICONE. MY PHYSICIAN HAS PUT ME ON 3 MEDICATIONS TO COMBAT THE REACTION AND POTENTIAL INFECTION.