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
Manufacturer
Areza Medical/advanced Medical Associates, Llc.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.