inforMED
InjuryMDA

EMBRACE SILICONE SCAR TREATMENT

Received Nov 29, 2023 · Event occurred Oct 10, 2023

Report MW5148580 · MDR key 18238556

Device

Generic name

Elastomer, Silicone, For Scar Management

Patient

54 YR · Female

  • Hypersensitivity/Allergic reaction
  • Pain
  • Caustic/Chemical Burns
  • Hypersensitivity/Allergic reaction
  • Pain
  • Caustic/Chemical Burns

Narrative

Description of Event or Problem

PRODUCT ADHESIVE CONTAINS LATEX (A LATEX ACCELERATOR). THE PRODUCT CAUSED A CHEMICAL BURN ON CONTACT. THE CHEMICAL BURN IS STILL PRESENT AND PAINFUL TWO WEEKS AFTER SKIN CONTACT. PRODUCT PACKAGING DOES NOT PROVIDE INGREDIENTS. PACKAGING DOES NOT INCLUDE A LATEX WARNING. PRODUCT REPRESENTATIVE TWICE REFUSED TO PROVIDE INGREDIENTS WHEN CONTACTED DIRECTLY. PRODUCT PACKAGING FALSELY CLAIMS THE PRODUCT IN ITS CURRENT FORM IS FDA CLEARED. THERE ARE MANY PRODUCT REVIEWERS ON AMAZON WHO HAVE EXPERIENCED A SIMILAR OR MORE SEVERE ALLERGIC REACTION. SEVERAL FEAR THE AREA OF CONTENT COULD HAVE A SECONDARY INFECTION.