FDA.reportPublic FDA data

MAUDE MDR 609507

MDR report key
609507
Report number
2247247-2005-00001
Event key
0
Event type
3
Date of event
2005-04-15
Date received
2005-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHILIPSSUN TANNING LAMPSPHILIPS LIGHTING B.V.IEHADVANTAGE 808 140W136408NOVEMBER 2004NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-05-2701. O

Event Narratives#

D

Patient 1

IN 2005 PLC WAS CONTACTED BY ITS DISTRIBUTOR WHO REPORTED THAT SEVERAL CUSTOMERS ALLEGEDLY RECEIVED INJURIES AFTER USING TANNING DEVICES ALLEGEDLY EQUIPPED WITH SUN TANNING LAMPS MANUFACTURED BY PHILIPS LIGHTING COMPANY. THE CUSTOMERS ALLEGEDLY RECEIVED CRANBERRY COLORED STRIPES FROM THEIR BREASTS TO THEIR KNEES RESULTING IN SOME OF THE CUSTOMERS OBTAINING MEDICAL CARE. THE REPORT INDICATED THAT SOME OF THE CUSTOMERS CLAIMED THEY SUSTAINED SECOND DEGREE BURNS. WHEN CONTACTED BY PLC, THE SALON OWNER ADVISED THAT 3 CUSTOMERS CLAIMED INJURIES, BUT HAS BEEN UNWILLING TO PROVIDE FURTHER INFO. IT IS REPORTED THAT THE TANNING DEVICES USED BY THESE CUSTOMERS WERE ALLEGEDLY EQUIPPED BY THE SALON OPERATOR WITH TANNING LAMPS MANUFACTURED BY PHILIPS LIGHTING COMPANY. IT IS ALSO REPORTED THAT THE LAMPS INSTALLED BY THE SALON OPERATOR WERE MANUFACTURED BY PHILIPS AND WERE NOT COMPATIBLE WITH THE LAMPS SPECIFIED BY THE TANNING DEVICE MANUFACTURER. IT IS ALSO REPORTED THAT THE SALON OPERATOR RESET THE TANNING DEVICE TIMER.