inforMED
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

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.