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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEGADERM DRESSING, WOUND, OCCLUSIVE

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TEGADERM DRESSING, WOUND, OCCLUSIVE Back to Search Results
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).
 
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Brand NameTEGADERM
Type of DeviceDRESSING, WOUND, OCCLUSIVE
MDR Report Key9161658
MDR Text Key161521296
Report NumberMW5090241
Device Sequence Number2
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/04/2019 Patient Sequence Number: 1
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