FDA Adverse Event Injury Summary report: N

VERILUX PHOTOTHERAPY

MDR report key: 19373684 · Received May 21, 2024

Report

Report Number
MW5155217
Event Type
Injury
Date Received
May 21, 2024
Date of Event
January 1, 2023
Report Date
May 21, 2024
Manufacturer
BEAR DOWN BRANDS, LLC
Product Code
KZF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

REPORTER CALLING, STATING SHE IS ABOUT TO UNDERGO HER FOURTH SURGICAL PROCEDURE FOR "BASAL CELL AND SQUAMOUS CELL" CANCER REMOVAL AS A RESULT OF VERILUX PHOTOTHERAPY USE. REPORTER STATES SHE USED THE VERILUX DEVICE "REGULARLY FOR ABOUT SIX TO SEVEN MONTHS" IN 2023. REPORTER STATES AFTER SHE WAS USING THE DEVICE, SHE READ SOME INFORMATION ONLINE ABOUT HOW THIS DEVICE CAN CAUSE SKIN CANCERS AND SHE STATES SHE STOPPED USING IT IMMEDIATELY. REPORTER STATES AFTER SHE STOPPED USING THE DEVICE SHE DEVELOPED BASAL CELL AND SQUAMOUS CELL SKIN CANCER AND HAS HAD TO UNDERGO NUMEROUS SURGICAL PROCEDURES EVER SINCE, HER FOURTH SUCH PROCEDURE HAPPENING LATER ON THIS WEEK. REPORTER STATES SHE CAN'T LEAVE HER HOME AFTER THE SURGERIES BECAUSE SHE HAS STITCHES ON HER FACE AND DOESN'T WANT TO BE SEEN IN PUBLIC LIKE THAT. REPORTER STATES SHE PERFORMED MORE ONLINE RESEARCH AND DISCOVERED VERILUX IS BEING SOLD "ILLEGALLY" ACROSS VARIOUS SITES ON THE INTERNET. REPORTER STATES SHE CONTACTED THE COMPANY AND STATES A COMPANY REPRESENTATIVE TOLD HER "WE NEVER SENT THE PAPERWORK IN" FOR "REGULATORY APPROVAL". REPORTER STATES SHE WANTS TO PURSUE LEGAL ACTION AGAINST THE COMPANY AND "I WANT TO BE COMPENSATED" BY THE COMPANY FOR HER SURGERIES AND MEDICAL EXPENSES AS A RESULT OF VERILUX USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2298994 VERILUX PHOTOTHERAPY DEVICE, MEDICAL EXAMINATION, AC POWERED KZF BEAR DOWN BRANDS, LLC

Patients

Seq Age Sex Outcome Treatment
1 79 YR Female Other