BLUE DREAM SUN SURROUND
Received May 11, 2000 · Event occurred Jan 1, 2000
Report MW4002769 · MDR key 278591
Device
Generic name
Mega Tanning Bed
Manufacturer
Dr. Kern Usa, Inc.Model number
NICatalog number
NI
Lot number
NA
Product problems
- Inadequate Instructions for Healthcare Professional
- Nonstandard Device
- Reaction
- Radiation overexposure
Patient
NO INFO
- Rash
- Skin Discoloration
Narrative
Description of Event or Problem
CONSUMER WAS GIVEN A GIFT CERTIFICATE FOR A SERIES OF TANNING SESSIONS. THE FIRST TIME THEY VISITED THE SALON, CONSUMER USED ONE OF THE REGULAR BEDS FOR 11 MINS WITH NO PROBLEM. ON SECOND VISIT, THE EMPLOYEE AT THE DESK (A NEW EMPLOYEE, ACCORDING TO CONSUMER) PUT CONSUMER IN THE "MEGA" BED. THE EMPLOYEE TOLD CONSUMER THAT BECAUSE THEY HAD DARK SKIN, THEY COULD STAY IN THE BED FOR A TOTAL OF 10 MINS. THE NEXT DAY, CONSUMER NOTICED A RASH ALL OVER LEGS. FOUR DAYS AFTER THAT, NOTICED SPLOTCHY BROWN SPOTS ON LEFT RING AND PINKIE FINGERS. VISITED THE SALON AGAIN AND SHOWED THE MGR THEIR FINGERS. THEY SAID THE SPLOTCHES LOOKED LIKE SUN DAMAGE, AND THAT THE EMPLOYEE SHOULD HAVE ONLY ALLOWED THEM TO STAY IN THE MEGA BED FOR 4-6 MINS. EMPLOYEE SAID CONSUMER COULD HAVE STAYED IN FOR 10 MINS IF IT HAD BEEN THE FIFTH WEEK OF TANNING. THE MGR ALSO TOLD CONSUMER THAT THIS PARTICULAR EMPLOYEE WAS NEW AND THAT THIS WAS THE SECOND OR THIRD TIME "THEY'VE DONE THIS". CONSUMER ALSO REPORTED THAT THEY CONSULTED A PHYSICIAN ABOUT THE SPLOTCHINESS. THE PHYSICIAN TOLD CONSUMER THEY LOOKED LIKE SUN SPOTS. FIELD OFFICER PERFORMED A SUNLAMP PRODUCT FIELD TEST ON THE TANNING BED AND OBSERVED THAT THE LABEL ON THE UNIT SETS A LIMIT OF TEN MINS PER SESSION FOR PERSONS WITH "DARK SKIN" DURING "WEEK 1" OF TANNING. RPTR OBSERVED THE LABEL TO STATE A MAXIMUM LIMIT OF 20 MINS PER SESSION (WHEN MORE THAN THREE WEEKS OF TANNING EXPERIENCE HAS BEEN ACHIEVED). THE SUNLAMPS OBSERVED IN THE BASE OF THE SUNBED WERE LABELED IN PART AS PURETAN, 1-800-338-8267, P/N 035.B.A5.1000, FR71 SPECTRALARIUM R+. THE LABEL ON THE TANNING BED CALLS FOR "DR KERN LAMPS SER 100W, SER 25W AND 400W HP - LAMPS OR COMPATIBLE TYPES". A PREVIOUS COMPLAINT FILED IN 2/99) STATED THAT MAXIMUM EXPOSURE LIMITS HAD BEEN REDUCED FOR CERTAIN DR KERN SUNBEDS. IN THE AFTERNOON OF 3/23/2000, FIELD OFFICER OBSERVED ON THE DR KERN WEBSITE (WWW.DRKERN.COM) THAT THE CURRENT MAXIMUM TIME LIMIT FOR THE BLUE DREAM SUN SURROUND UNIT IS 15 MINS. ON 4/17/2000 TANNING SALON COMMITTED BY TELEPHONE TO CORRECT THE UNIT BY EITHER DOCUMENTING SUNLAMP COMPATIBILITY WITH THE TANNING BED, OR (IF THAT COULD NOT BE ACCOMPLISHED) BE REMOVING THE PURETAN SUNLAMPS FROM THE TANNING BED AND SELLING THE UNIT WITH NO SUNLAMPS IN IT.