MAUDE Adverse Event Report: TEGADERM; DRESSING, WOUND, OCCLUSIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146)

Event Date 09/18/2019

Event Type  Injury  

Event Description

I had a severe skin reaction to the product saniderm, it is a plastic film covering marketed as a wound cover to promote healing.Its main focus is the tattoo community and to be used as aftercare to promote fast safe healing.I have never used this product before instructions vary slightly depending on who gives you the product.The artist that performs the tattoo explains the aftercare basically.The product was placed on towel blotted skin that was cleaned off with sanitizer foam/soap, the tattoo was still bleeding.I left it on for a little over 24 hours and no leaking occurred.I removed it and cleaned the whole area and then let it air dry for around 4-8 hours with no contact of anything.I applied a second similar type of product named tegaderm and left that for around 6 hours before noticing some burning and itching.I was at work and could not remove dressing until i got home and then noticed the severity of the reaction.I have pictures to prove, it was the original product not the second due to the placement and size difference.I would like to know the adhesive used in saniderm, so i can prevent this from happening again.Thank you.Fda safety report id# (b)(4).

• Brand Name: TEGADERM
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• MDR Report Key: 9161658
• MDR Text Key: 161521296
• Report Number: MW5090241
• Device Sequence Number: 2
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR