• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DR. KERN USA, INC.BLUE DREAM SUN SURROUNDMEGA TANNING BED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

DR. KERN USA, INC. BLUE DREAM SUN SURROUND MEGA TANNING BED   Back to Search Results
Event Date 01/01/2000
Event Type  Other   Patient Outcome  Other
Event Description

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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBLUE DREAM SUN SURROUND
Type of DeviceMEGA TANNING BED
Manufacturer (Section F)
DR. KERN USA, INC.
10860 alder circle
dallas TX 75238
Manufacturer (Section D)
DR. KERN USA, INC.
10860 alder circle
dallas TX 75238
Device Event Key269648
MDR Report Key278591
Event Key261256
Report NumberMW4002769
Device Sequence Number1
Product CodeLEJ
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/16/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
OTHER Device ID NumberNI
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 05/11/2000 Patient Sequence Number: 1
#TreatmentTreatment Date
PURETAN SUNLAMPS P/N 035.B.A.S. 1000 FR 71
SPECTRALARIUM RT
-
-