FDA Adverse Event Injury Summary report: N

SPERTI SUNLAMPS

MDR report key: 14251616 · Received April 29, 2022

Report

Report Number: 1022129-2022-00001
Event Type: Injury
Date Received: April 29, 2022
Date of Event: February 26, 2022
Report Date: March 8, 2022
Manufacturer: KBD INC
Product Code: LEJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE USER PURCHASED THE DEVICE ON (B)(6) 2022 VIA (B)(6) MARKETPLACE. SHE CONTACTED US THROUGH (B)(6)'S MESSAGING SYSTEM ON (B)(6) 2022 TO REPORT A BURN. WE HAVE ATTEMPTED TO CONTACT HER THROUGH THE (B)(6)'S MESSAGING SYSTEM TO SPEAK VIA TELEPHONE TO CONDUCT AN INTERVIEW TO GATHER THE NECESSARY INFORMATION FOR THIS MDR FILING. HOWEVER, THE CUSTOMER HAS BEEN UNRESPONSIVE. WE HAVE ADDITIONALLY TRIED TO SEARCH HER NAME, CITY AND STATE VIA (B)(6) TO FURTHER TRY AND CONTACT HER. BUT, WE HAVE BEEN UNSUCCESSFUL. WE HAVE PROVIDED A COPY OF THE USER MANUAL OF THE FIJI SUN TANNING LAMP WHICH INCLUDES A PRODUCT LABEL THAT IS ATTACHED TO THE BACK OF THE DEVICE. THE LABEL AND MANUAL INCLUDES INSTRUCTIONS FOR USE AND EXPOSURE SCHEDULE PER 21 CFR 1040.20. THE BACK DEVICE LABEL INCLUDES WARNINGS OF: ULTRAVIOLET RADIATION. FOLLOW INSTRUCTIONS. AVOID OVEREXPOSURE.' INITIAL EXPOSURE SHOULD NOT EXCEED 3 MINUTES FOR ALL SKIN TYPES AS A DISTANCE OF 18" PER SESSION. EXPOSURE AT A DISTANCE LESS THAN 18" IS NOT RECOMMENDED.' FOLLOW EXPOSURE SCHEDULE FOR APPROPRIATE SKIN TYPE. THE USE OF EXPOSURE POSITION OTHER THAN THE RECOMMENDED DISTANCE MAY RESULTS IN OVEREXPOSURE.'

Description of Event or Problem · 0

THE DEVICE USER REPORTED A BURN AFTER USING THE FIJI SUN TANNING LAMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1694080	SPERTI SUNLAMPS	FIJI SUN TANNING LAMP	LEJ	KBD INC	FIJISUN	821U

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Other