EPI-DERM EDGTNT-5106Recalls & reported problems

Biodermis LLC · TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 5 Pack · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852260000517), received between Jul 14, 2026 and Jul 14, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Biocompatibility1
Off-Label Use1

Patient problems

Skin Inflammation/ Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 14, 2026Off-Label Use; Biocompatibility
USER APPLIED SILICONE GEL STRIPS TO A SCAR. THEY CLAIMED THAT THE SILICONE STRIPS CAUSED AN ADVERSE SKIN REACTION REQUIRING A TRIP TO THE HOSPITAL AND TREATMENT WITH MEDICATION. EXACT TEXT FROM USER, WHO PURCHASED PRODUCT ON AMAZON.COM AND PROVIDED INFORMATION THROUGH AMAZON.COM: EPIDERM SILICONE GEL SCAR STRIPS. ORDER ID: (B)(4). AFTER USING THE PRODUCT ON A RECENT SURGICAL SCAR, I EXPERIENCED A SIGNIFICANT ADVERSE SKIN REACTION THAT REQUIRED EMERGENCY MEDICAL TREATMENT. AS A RESULT, I INCURRED MEDICAL EXPENSES IN ADDITION TO THE COST OF THE PRODUCT. I HAVE PHOTOGRAPHS OF THE AFFECTED AREA AND DOCUMENTATION RELATING TO THE MEDICAL TREATMENT I RECEIVED. BEFORE PURSUING ANY FURTHER ACTION, I WOULD LIKE TO PROVIDE YOU WITH AN OPPORTUNITY TO REVIEW THIS MATTER AND DISCUSS AN APPROPRIATE RESOLUTION, INCLUDING CONSIDERATION OF THE EXPENSES I INCURRED AS A RESULT OF THIS INCIDENT. PLEASE LET ME KNOW HOW YOU WOULD LIKE TO PROCEED. I LOOK FORWARD TO YOUR RESPONSE. THANK YOU.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25820079 ↗

Device details

UDI-DI	`00852260000517`
Brand	EPI-DERM
Model	EDGTNT-5106
Company	Biodermis LLC
Product code	MDA · Elastomer, Silicone, For Scar Management
Class	Class 1
FDA submission	K003948
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 4, 2025

Device type (GMDN): Scar-management dressing, reusable

A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.

Other Elastomer, Silicone, For Scar Management devices

ScarAway Silicone Clear Scar Sheets Lot Code
Alliance Pharma Inc. · Elastomer, Silicone, For Scar Management
1 report

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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