BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANIDERM

    MDR report key: 9161658 · Received October 4, 2019

    Report

    Report Number
    MW5090241
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 27, 2019
    Manufacturer
    SANIDERM MEDICAL, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952879 SANIDERM TAPE AND BANDAGE, ADHESIVE KGX SANIDERM MEDICAL, LLC
    952880 TEGADERM DRESSING, WOUND, OCCLUSIVE NAD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention