FDA Adverse Event Injury Summary report: N

LASER FOR TATTOO REMOVAL

MDR report key: 18574023 · Received January 23, 2024

Report

Report Number
MW5150685
Event Type
Injury
Date Received
January 23, 2024
Date of Event
April 1, 2021
Report Date
January 19, 2024
Manufacturer
UNK
Product Code
QHF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I WENT TO (B)(6) EARLY 2021 TO BEGIN TATTOO REMOVAL FOR A LARGE TATTOO ON MY THIGH, AND A SMALLER NAME ON MY BACK THAT WAS BENEATH ANOTHER TATTOO. AFTER THE THIRD/FOURTH VISIT I ENDED UP USING THE (B)(6) LOCATION SINCE I COULDN'T GET IN AT THE OTHER. AT THIS VISIT I NOTICED THAT SOME SORT OF WHITE OUTLINE WAS DRAWN AROUND MY TATTOOS PRIOR TO USING THE LASER. I INQUIRED WHAT IT WAS, AND IT WAS EXPLAINED TO ME THAT IT WAS TO PROTECT MY SURROUNDING SKIN. I WAS CAUGHT OFF GUARD BEING THAT I WAS IN THE THIRD OR FOURTH VISIT AND THIS HAD NEVER BEEN DONE. I WAS ALREADY NOTICING WHAT I KNOW IS "HALOING" AROUND MY THIGH TATTOO. I ASKED THE CLINICIAN ABOUT THE HALOING AND WAS TOLD THAT I SHOULD SPACE OUT MY SESSIONS. AT THE TIME I WAS COMING IN EVERY 4-6 WEEKS, I BELIEVE, AND WAS SWITCHED TO EVERY 90 DAYS. DURING THE SAME VISIT, WHILE SHE WAS SUPPOSED TO BE REMOVING THE NAME UNDERNEATH THE TATTOO ON MY BACK, I NOTICED THAT SHE WAS ACTUALLY REMOVING THE LARGER TATTOO FROM MY BACK. SHE WAS APOLOGETIC, BUT THE DAMAGE HAD BEEN DONE. I DIDN'T PUT UP A HUGE ISSUE ABOUT IT, ALTHOUGH FOUND IT TO BE VERY CARELESS. SHE SET MY APPOINT AND I CONTINUED TREATMENT THROUGH (B)(6) 2023. I'D WAITED SIX MONTHS BETWEEN THIS DATE AND MY PRIOR APPOINTMENT BECAUSE THE HALOING ON MY LEG WAS GETTING PROGRESSIVELY WORSE. WHEN I CAME IN FOR THIS APPOINTMENT THERE WAS A NEW CLINICIAN WHO REFUSED TO TREAT ME, BECAUSE SHE SAID "MY SKIN WAS DAMAGED, AND SHE DID NOT WANT TO DAMAGE IT FURTHER." UNDERSTAND, THIS WAS THE SAME SUSPICION I HAD, BUT WAS STILL BEING LIED TO AND LASERED. I WAS USHERED INTO ANOTHER ROOM WHERE I WAITED FOR THE MANAGER. I WAS ADVISED THAT THEY WOULD NEED TO SPEAK WITH THEIR CLINICAL TEAM TO SEE WHAT THE COURSE OF ACTION WOULD BE, AND SOMEONE WOULD REACH OUT. THIS WAS RIGHT BEFORE THANKSGIVING SO I WAS PATIENT. I NEVER GOT A CALL. I REACHED OUT AGAIN IN DECEMBER, WITH THE SAME UNDERSTANDING, BUT STILL HEARD NOTHING ASIDE FROM A TEXT REITERATING THAT THE CLINICAL TEAM WOULD REACH OUT. IT IS NOW (B)(6) 2024, A DIFFERENT YEAR AND I HAVE NOT HEARD FROM THIS COMPANY. I AM OUT OF $(B)(6). MY SKIN IS DAMAGED, AND THE WRONG TATTOO ON MY BACK HAS BEEN LASERED. I'VE BEEN MISLEAD, LIED TO AND LEFT WITH NOTHING ASIDE FROM CONFUSION. I WOULD LIKE THIS COMPANY TO BE HELD ACCOUNTABLE FOR WHAT HAS BEEN DONE TO ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1056593 LASER FOR TATTOO REMOVAL ENERGY BASED DEVICE FOR TREATMENT OF TATTOOS QHF UNK

Patients

Seq Age Sex Outcome Treatment
1 42 YR Female