MELANOIR Adverse event report

Report an adverse event

Melanoir Co., Ltd. · English

This is the channel for reporting an adverse event or reaction involving a Melanoir product. Anyone may use it — the artist who did the tattoo, the person who received it, or someone writing on their behalf. It goes to us directly, not to a call centre.

Before you fill this in

SEEK MEDICAL CARE FIRST

If anyone needs medical attention, get it before you do anything else. Reporting here is not a substitute for medical care.

This page is a record channel. Nothing on it is medical advice, and we cannot diagnose or treat anything from a form. If the situation is urgent, contact a physician or your local emergency service.

Send the report once care is under way. Partial information is still worth sending — fill in what you know and describe the rest in your own words.

The report

Photographs optional

Everything below is used to record what happened, to trace the batch involved, and to reach you if we need to ask something. Only three things are actually needed to send it — the country, who you are reporting as, and what happened. Everything else is asked because it makes the report more useful, not because it is a condition of being heard.

The name of the person making this report. If you are writing on someone else's behalf, put your own name here and say so in the description.

Where we write if we need more detail.

REPORTING WITHOUT YOUR NAME

Both fields above can be left empty, and the report will still be recorded and still counts. The trade-off is simply that we then have no way to come back to you with questions — and follow-up questions are often what turns a report into something we can act on. If that matters to you, leave an email even if you leave the name blank.

The country where the tattoo was done. Needed — it decides which authority the report may have to reach.

Who is reporting

Printed on the package, near the expiry date. This is the single most useful thing you can give us — it ties the report to one production batch, so we can check every other unit made at the same time. Look for it before you tick the box; but a report without it is still worth far more to us than no report at all.

Where a product was registered with us, the batch is already on our record. An email address or an order reference lets us recover it without the packaging. Leave it blank if the product was not registered — that changes nothing about how the report is handled.

These are two different dates and we ask for both. A reaction can appear the same day, or days and weeks after the tattoo was done, and the interval between the two is part of what we need to read. An approximate date is much better than none — give your closest estimate and say so in the description, and only tick the box if you truly cannot place it.

Outcome

Check every one that applies. If none of them apply, leave them all unchecked and simply describe what happened below.

In your own words. What appeared, where on the body, how it changed over time, and whether anyone has seen it clinically. If you know the product, the area treated, the technique, or any medication involved, include that too. Up to 4,000 characters.

Photographs — optional

    Optional. A report without photographs is still a complete report. Anything you attach is resized and stripped of embedded location and time data in your browser before it is sent.

    ABOUT THE PHOTOGRAPHS
    1. Each image is resized and re-saved inside your browser before anything is sent — the longest edge reduced to at most 2,000 pixels and the file re-encoded as a JPEG.
    2. Re-encoding discards the embedded camera data: the capture time and, where the device records it, the location where the photograph was taken. That metadata never leaves your device.
    3. The original file on your device is not uploaded and not altered. We do not need it — this is a record of what a reaction looked like, not a colour reference.
    4. What is uploaded sits in private storage. It is not published, not indexed, and not shared with anyone outside Melanoir except where a regulator requires it.

    Read the privacy notice

    What happens to this report

    What we hold
    What you enter aboveWhatever of the following you choose to give: your name, email, country, your role, the LOT number, any registration reference, the two dates, the outcomes you check, your description, and any photographs you attach. Fields you leave blank are stored as blank, not guessed at.
    Why
    To record and traceA report is checked against the production record for that batch. That is the whole reason the LOT number is asked for.
    Who else sees it
    Regulators, where the law requiresReports may be passed to the United States Food and Drug Administration, and to the equivalent authority in your country, where we are legally required to do so. Nothing here is published.
    Stored in
    SingaporeOur database and file storage are hosted in ap-southeast-1. If you are in the United States, the EU, the UK, or another region with transfer rules, your data leaves it when you send this form.
    How long
    6 yearsRequired by 21 U.S.C. §364a(e)(1), whether or not the report goes to the FDA. We cannot delete a report inside that period on request.
    Controller
    Melanoir Co., Ltd.410 Jeongseojin-ro, Seohae-gu, Incheon, Republic of Korea

    A copy of what we hold, a correction, or deletion: one email to official@melanoir.co.kr covers all of it, though a record we are required by law to retain is the one thing we cannot delete on request. Full detail in the privacy notice.