inforMED
InjuryMDA

SCAR SILICONE GEL SHEET

Received Nov 29, 2023 · Event occurred Oct 15, 2023

Report MW5148585 · MDR key 18239177

Device

Generic name

Elastomer, Silicone, For Scar Management

Patient

55 YR · Female

  • Erythema
  • Hypersensitivity/Allergic reaction
  • Itching Sensation
  • Erythema
  • Hypersensitivity/Allergic reaction
  • Itching Sensation

Narrative

Description of Event or Problem

THIS PRODUCT OR ITS ADHESIVE CONTAINS LATEX (OR A LATEX ACCELERATOR). WHEN REMOVING THIS PRODUCT FROM ITS INNER PACKAGING, IN LESS THAN 15 SECONDS, MY FINGERS TOUCHING THE OPEN GEL PRODUCT TURNED RED AND WERE ITCHY FOR HOURS AFTER. I IMMEDIATELY SEALED THIS PRODUCT IN A BAG AND THREW THE PRODUCT IN A TRASH CAN OUTSIDE MY HOME. PRODUCT PACKAGING DOES NOT DISCLOSE PRODUCT INGREDIENTS. THE PACKAGING DOES NOT DISPLAY A LATEX WARNING. THE PRODUCT'S PACKAGING CLAIMS THE PRODUCT IS HYPOALLERGENIC.