MAUDE Adverse Event Report: BIODERMIS LLC EPIDERM SILICONE GEL SCAR STRIPS; EPI-DERM SILICONE GEL SHEETING

Model Number	EDGTNT-5106
Medical Device Problem Codes	Off-Label Use (1494); Biocompatibility (2886)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting potential skin reaction for the device in abundance of caution.The customer that notified the manufacturer of the injury provided a photo of the site and an electronic image of a hospital invoice.The customer indicated that the device was placed on a recent surgical site, with a photo showing a site with stitches.This would be outside the intended use of the device, as the contraindications on the product state: do not use on open wounds or when any dermatological conditions disrupt the skin (such as a rash).The documentation provided to prove an injury had occurred - an electronic image of a hospital invoice - had a disclaimer on the bottom of the image indicating that the document was not an actual invoice.Further, the product was purchased through an online retailer and shipped to rochester new york.The electronic image of the hospital invoice showed it was from a healthcare facility in minneapolis, minnesota.Multiple attempts were made to gather the product that caused the alleged injury, lot information, and more information about the injury to verify accuracy.No additional information was provided, making it impossible to validate the injury and subsequent medical care.The customer was seeking immediate compensation for the injury, and our evaluation was that the lack of evidence and inconsistencies in the hospital invoice suggest that an injury likely did not occur.Regardless, we felt that it is appropriate to report the incident as a possible skin reaction.
Event or Problem Description
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.

• Brand Name: EPIDERM SILICONE GEL SCAR STRIPS
• Common Device Name: EPI-DERM SILICONE GEL SHEETING
• Manufacturer (Section D): BIODERMIS LLC; 1820 whitney mesa drive; suite 100; henderson NV 89014
• Manufacturer (Section G): BIODERMIS LLC; 1820 whitney mesa drive; suite 100; henderson NV 89014
• Manufacturer Contact: alan dye ; 1820 whitney mesa drive; suite 100; henderson, NV 89014 ; 7022604466
• MDR Report Key: 25820079
• Report Number: 1000135565-2026-02620
• Device Sequence Number: 10734141
• Product Code: MDA
• UDI-Device Identifier: 00852260000517
• UDI-Public: 00852260000517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: EDGTNT-5106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female